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GDSN for the FDA Global Unique Device Identifier Database
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1. UoM Pending UoM UN 2P Kilobyte A unit of information equal to 103 Recommendation 20 1000 bytes UoM Pending UoM UN 4G Microlitre A microlitre is one millionth of a litre Recommendation 20 UoM Pending UoM UN 4L Megabyte A unit of information equal to 10 Recommendation 20 1000000 bytes UoM Pending UoM UN A86 Gigahertz A unit of frenquecy equal to 109 Hertz Recommendation 20 UoM Pending UoM UN AD Byte A unit of information equal to 8 bits Recommendation 20 UoM Pending UoM UN ANN Year Unit of time equal to 365 25 days Recommendation 20 UoM Pending UoM UN APZ Troy ounce or The troy ounce is a unit of imperial Recommendation 20 apothecary ounce measure In the present day it is most commonly used to gauge the weight and therefore the price of precious metals One troy ounce equals 480 grains or 31 1035 grams UoM Pending UoM UN BB Base box A unit of area of 112 sheets of tin mil Recommendation 20 products tin plate tin free steel or black plate 14 by 20 inches or 31 360 square inches UoM Pending UoM UN BFT Board Foot A specialized unit of measure for the Recommendation 20 volume of rough lumber before drying and planing with no adjustments or planed surfaced lumber It is the volume of a one foot length of a board one foot wide and one inch thick Some countries utilize the synonym super foot or superficial foot UoM Pending UoM UN BLL Barrel US There are varying standards for barrel Recomme
2. eeee 5 1 3 3 Automatic Identification and Data Capture AIDC Marking cc cccceeeeeseeteeeeeseeeeeeeeeeeeeeeees 6 1 3 4 The role of Global Location Number GLN in UDI 0 0 0 eeceeeeeeeceeeeeeeeeeeeeee teense seaeeeeaeeeeneeees 6 135 GDSN Knowledge sissid naa aa a dawesnds AEE Sa aa Ea Eaa aeia 6 1 4 What is UDI and G UDID esise sriiininennnnnianidaren i aeea aaa aea ana aaea aa E aaa aaiae 7 1 5 Master Data Management and Governance cccccceeeeeeeeneeceeeeeeeaeeeeeeeseaeeecaaeseeaaeseeeeeseaeeseaeeeeneeee 7 L6 Datta QALY crcire oonan aiea aana Ea aaa aa aaa aaa aaa aaa a aa aeaea a aa 8 te Data Management sis E E S 8 1 8 Data Governance srsrcornissrannn a dea eet dis ie a aa aa 9 1 9 Roles and Responsibilities cccc icceeiie ieee eters Gee een 10 2a E Date FiO sccccacssstcsssccetestsecocesericcaccesaneasucateeancencaeuccaue naneeensaasedaue seuneeeeebvecantaeceiseasbceaaneeinn 10 3 MARTE Data Re itemMentS sssri rnision eaaa Ena raana Sraa anaia atrae 12 4 GSI GDSN to FDA GUDID MappiNg iisisccisicsscscacsacciasccasccasciasdcncacacsssaissiaisansiananinaiamiannanine 33 5 FDA GUDID mapping to GS1 code values eceeceeeeeeeeeeeeeeeeeeeeenneeeeeeneeneeeeeeeeeeenseseanees 50 6 Guidance on populating ValUCS ccccccesssssseeeeeeeeeeeeeeeseneaeeneneeeeeeeeseeseseneneeeeesesseeseeeanees 106 Ds MACUU COS tessa ss ceca ccc eters E cer E cai ceed feds see ences aren
3. Additional Trade Item Identification Type ICCBBA GDSN Change Request CR is in process to add this Issue 1 Apr 2014 All contents copyright GS1 Page 93 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value Description Definition where needed code value Serial Number TRUE serialNumberLocationCode MARKED_ON_PACKA Serial number is on the trade item s GING packaging Serial Number TRUE serialNumberLocationCode MARKED_ON_PACKA Serial number is on the trade item s GING_INSERT packaging insert Serial Number TRUE serialNumberLocationCode MARKED_ON_TRADE_ Serial number is on the trade item ITEM Serial Number FALSE serialNumberLocationCode NOT_MARKED The trade item or its packaging is not marked Serial Number FALSE serialNumberLocationCode UNKNOWN Unknown location of marking SizeType Circumference Clinical SizeType Circumference SizeType Depth Clinical SizeType Depth SizeType Device Size Text Clinical SizeType Device Size Text specify specify SizeType French Catheter Clinical SizeType French Catheter Gauge Gauge SizeType Greatest Diameter Clinical SizeType Greatest Diameter SizeType Height Clinical SizeType Height SizeType Length Clinical SizeType Length SizeType Lumen Diameter Clinical SizeType Lumen Diameter SizeType Needle Gauge Clinica
4. Issue 1 Apr 2014 All contents copyright GS1 Page 90 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TSS Trunk Salesmen Sample Trunk Salesmen Sample Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TUB Tub Tub Generally a round flat bottomed container closed with a large lid typically used to contain ice cream margarine sour cream confections and other products Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code UNP Unpacked Unpacked The item is provided without packaging Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed t
5. GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition opening which may later be closed by a gummed or adhesive flap heat seal tie st Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code EPR Edge Protection Edge Protection A right angle piece placed over the outermost perimeter edges of a container to distribute pressure and prevent collapse or cutting from banding strapping or handling Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code FIR Firkin Firkin Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code FLO Flo bin Flo bin Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code FRM Frame Frame Packaging Type GDSN utilizes the code value however GUDID cu
6. glove boxes ina Carton Package DI 201 the UDI on the Carton 5 Cartons ina Case Package DI 301 the UDI on the Case contains a 5 cartons with DI 201 with 4 glove boxes ina carton 10 glove boxes ina Carton Package Dl 202 the UDI on the All contents copyright GS1 GS1 14 digit N A Number is an alternate numeric value or delete after there is a Alphanumeric secondary HIBCC 6 23 Grace Period Secondary DI 6 23 lookup for a character Number characters medical device alphanumeric that is issued value ICCBBA from a different 10 or 16 issuing agency character than the primary alphanumeric DI value NHRIC 10 digit numeric value Package DI Can add Package Configuration after Grace Period but cannot delete or edit Package Configurations entered prior to the end of the Grace Period Package DI A device GS1 14 digit Can add after 0 Not Required Alphanumeric N A Number identifier for the numeric value Grace Period Required if 6 23 package HIBCC 6 23 but cannot Package depending on configuration character delete Configuration is Issuing that contains alphanumeric entered Agency multiple units of value ICCBBA the base 10 or 16 package does character not include alphanumeric shipping value containers For example 4 Carton A a S a S Page 19 of 163 Quantity per Package The number of packages with a unique primary DI within a given packaging con
7. Alphanumeric Special Storage Indicates any Can enter Can edit add or Free Text Conditions special storage alphanumeric delete after Required if 200 requirements for with symbols Grace Period Special Storage the device Condition Text selected Sterilization Method Device Indicates the Choose a value Cannot edit after 1 1 Boolean Yes No Packaged as medical device is from the drop Grace Period Required Sterile free from viable down microorganisms See ISO TS 11139 Requires Indicates that the Choose a value Cannot edit after 1 1 Boolean Yes No Sterilization device requires from the drop Grace Period Required Prior to Use sterilization prior down to use Sterilization Indicates the Choose a value Can edit add or 1 Required if N A Chlorine Dioxide Dry Heat Ethylene Oxide Method method s of from the drop delete after Requires High Intensity Light or Pulse Light sterilization that down Grace Period Sterilization Prior Hydrogen Peroxide Microwave Radiation can be used for only if Yes was_ to Use is Moist Heat or Steam Ozone Peracetic this device selected for marked Yes Acid Radiation Sound Waves Ultraviolet Requires Sterilization Prior to Use before Grace Period Cannot add Sterilization Methods after Grace Period if No was selected for Requires Sterilization Prior to Use before Grace Period Light Issue 1 Apr 2014 All contents copyr
8. Data Type Code List UoM qualifier GDSN Required OPTIONAL Final Deployment Attribute Name clinicalSizeValue Definition The value to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user For example 16 gauge for a needle or 200 cc for a syringe Carries a UoM from the Recommendation 20 code list Data Type Measurement numeric amp UoM qualifier GDSN Required OPTIONAL Population Guidance below This attribute has a temporary attribute AVP in GDSN clinicalSizeValueUoM It will be deployed into the GDSN Schema in 2016 17 into a final solution This GUDID attribute is a code list attribute specifying the clinical size unit of measure for the device s clinical size value This attribute is a numeric value and an associated Unit of Measure UoM qualifier The UoM is a code from the UN Recommendation 20 Code List The Data Pools will convert the UN Rec 20 code to the applicable code for the GUDID if needed For the GUDID the data pools will populate the numeric value in the GUDID attribute Value and the UoM qualifier in the GUDID attribute Unit of Measure For example for a 16 gauge needle the value is 16 and the UoM is H79 for a 20 cc syringe the value is 20 and the UoM is CQM This attribute is part of a repeatable class of clinical attributes for the device containing the Size Type Size Value and Size Unit of Measure for the device s clinical size Once published a 7
9. GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Issue 1 Apr 2014 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Document Summary Document Item Current Value Document Title GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Date Last Modified 27 January 2014 Current Document Issue Issue 1 Status Document Description Implementation guide for using the GDSN to populate a UDI database This version focuses on the U S FDA Global Unique Device Identifier Database GUDID Contributors Pete Alvarez GS1 Global Office Scott Brown GS1 US Change Log Issue No Date of Change Changed By Summary of Change 1 9 September 2013 Pete Alvarez Merger of sections created by Pete Alvarez Global Office and Scott Brown GS1 U S 2 6 January 2014 Scott Brown Updated section GDSN to GUDID Attribute Mapping and Guidance on Populating Attributes per latest FDA GUDID requirements and User Guide 3 8 January 2014 Final Review prior to submitting into the GSMP Disclaimer GS1 under its IP Policy seeks to avoid uncertainty regarding intellectual property claims by requiring the participants in the Work Group that developed this GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide to agree to grant to GS1 members a royalty free license or
10. or DUNS_ PLUS FOUR number can then populated in the GDSN attribute Additional Party Identification value The number populated in Additional Party Identification value will be populated in GUDID as the Labeler DUNS Number Company Name FDA GUDID Description Company name associated with the Labeler DUNS Number entered in the DI Record This name should match the company name on the device label Data Entry Notes System Populated Issue 1 Apr 2014 All contents copyright GS1 Page 109 of 163 7 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Edit Rules After Grace Period Can be edited through D amp B only Required 1 1 Required Data Type amp Length Alphanumeric Entry List of Values LOV N A New DI Trigger N A Public Private Status Public GS1 GDSN Attribute Name N A Definition N A Data Type N A GDSN Required N A Population Guidance below The FDA will populate this information into the GUDID based on information from D amp B based on the Labeler DUNS provided If the information is not correct D amp B should be contacted to facilitate correcting the data Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can only be changed with Dunn and Bradstreet D amp B Many of the data elements are locked and can no longer be edited Company Physical Address FDA GU
11. 6 23 depending on Issuing Agency Package Type Text to describe the outer packaging of the product and enables users to understand higher level packaging configurations Free text Can add with new package configuration after Grace Period but cannot delete 0 1 Not Required Alphanumeric 20 N A Package Discontinue Date Indicates the date this particular package configuration is discontinued by the labeler Choose date from calendar or manually enter in format mm dd yyyy Can add with new package configuration after Grace Period but cannot delete 0 Required if both Package Configuration and Commercial Distribution End Date are entered Numeric date format 10 N A Issue 1 Apr 2014 All contents copyright GS1 Page 21 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 0 Required if Indicates System N A Alphanumeric In Commercial Distribution Not in whether the populated Published Commercial Distribution package configuration is available or discontinued Support Contact Support Phone number Enter 10 digit Can edit add or 1 Required if Numeric 20 N A Contact Phone for the support North American delete after support contact 10 contact number For Grace Period information is international entered numbers start with Does no
12. Code List The maximum humidity in percentages in which the GUDID Code for Storage Type Handling environment humidity All contents copyright GS1 Page 47 of 163 Issue 1 Apr 2014 GS1 GDSN Attribute Name GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GDSN Data Type GDSN Definition trade items should be transported GDSN Notes transportationHumidityMinimum UoM Numeric Code List The minimum humidity in percentages in which the trade items should be transported GUDID Code for Storage Type Handling environment humidity transportationMaximumTemperature UoM Numeric Code List The maximum temperature that a trade item can be held at during transport as defined by the manufacturer without affecting product safety or quality GUDID Code for Storage Type Handling environment temperature transportationMinimumTemperature UoM t Numeric Code List The minimum temperature that a trade item can be held below during transport as defined by the manufacturer without affecting product safety or quality GUDID Code for Storage Type Handling environment temperature transportationMaximumTemperature UoM transportationMinimumTemperature UoM Numeric Code List t Numeric Code List The maximum temperature that a trade item can be held at during transport as defined by the manufacturer without affecting
13. Data Type amp Length Alphanumeric 6 23 depending on Issuing Agency Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name globalTradeltemNumber hierarchy levels where isTradeltemABaseUnit is FALSE Definition A particular Global trade item Number a numerical value used to uniquely identify a trade item A trade item is any trade item trade item or service upon which there is a need to retrieve pre defined information and that may be planned priced ordered delivered and or invoiced at any point in any supply chain Data Type Identifier 14 digits GDSN Required DEPENDENT not populated where isTradeltemABaseUnit is TRUE Population Guidance below The GUDID Package attributes are populated as a group and can not be entered as single elements in the message These attributes are Package DI Number Quantity per Package Contains DI Package Package Type Package Discontinue Date All packages must be entered If a new package level is created it is to be added to the GUDID as part of the Primary DI to which it is applicable This GDSN attribute references a GTIN in the hierarchy above the primary DI This would be or is one of the parent s of the primary DI See the example below Issue 1 Apr 2014 All contents copyright GS1 Page 121 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide In GDSN the following is pro
14. Drop down is for Webtool only Edit Rules After Grace Period Can edit add or delete after Grace Period Required 0 1 Not Required Data Type amp Length Numeric date format 10 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name lastShipDate Definition Indicates the latest date that the trade item can be shipped This is independent of any specific ship from location Data Type Date Time CCYY MM DDTHH MM SS GDSN Required OPTIONAL Population Guidance below This date signals that a trade item will no longer be in distribution from the Labeler Issue 1 Apr 2014 All contents copyright GS1 Page 115 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 14 Commercial Distribution Status FDA GUDID Description Indicates whether the device is in commercial distribution as defined under 21 CFR 807 3 b Data Entry Notes System Populated Edit Rules After Grace Period N A Required 0 1 Required if record is published Data Type amp Length N A Entry List of Values LOV In Commercial Distribution Not in Commercial Distribution New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name Derived by the FDA GUDID based on effectiveDate and lastShipDate Definition N A Data Type N A GDSN Required N A Population Guidance below If the current date is equal to or greater than the GUDID Publi
15. GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Packaging Type Code Code Value SLV Description where needed Sleeve Definition Sleeve A non rigid container usually made of paper cardboard or plastic that is open ended and is slid over the contents for protection or presentation Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code SPI SPL Spin Cylinders Spool Spin Cylinders Spool Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code SPR SRW Separator Divider Shrink Wrap Separator Divider In pack
16. Recommendation 20 mole UoM Pending UoM UN C34 Mole The mole symbol mol is the SI base unit of amount of substance one of a few units used to measure this Issue 1 Apr 2014 All contents copyright GS1 Page 98 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value Description Definition where needed physical quantity A mole will possess mass exactly equal to the substance s molecular or atomic weight in grams That is to say a substance s atomic or molecular mass in atomic mass units is the same as its molar mass in grams Because of this one can measure the number of moles in a pure substance by weighing it and comparing the result to its molecular or atomic weight UoM Pending UoM UN CA Case Recommendation 20 UoM Pending UoM UN CN Can Recommendation 20 UoM Pending UoM UN CQ Cartridge Recommendation 20 UoM Pending UoM UN CT Carton Recommendation 20 UoM Pending UoM UN CU Cup Recommendation 20 UoM Pending UoM UN CV Cover Recommendation 20 UoM Pending UoM UN D43 Atomic Mass Units Atomic Mass Units Recommendation 20 AMU UoM Pending UoM UN D70 Calorie A calorie is 1 100 of the amount of Recommendation 20 International Table energy required to warm one gram of IT air free water from 0 C to 100 C at standard atmospheric pressure this is about 4 190 J
17. Required 1 Required if there is a Secondary DI Number Data Type amp Length Numeric or Alphanumeric 6 23 characters Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name additionalTradeltemIdentificaton value Definition Data Type Text GDSN Required OPTIONAL Multiple Occurrence Population Guidance The GS1 General Specifications stipulate that a Trade Item can only have one GTIN As the GTIN is the primary DI for an item using GDSN to provide data to the GUDID a GTIN using GS1 as the issuing agency can not be a secondary DI However the item might have another issuing agency s item number standard in _ use Using the GDSN attribute additionalTradeltemldentificaton value these other issuing agency identifiers can be provided If a value is populated through GDSN for an issuing agency using the attribute additionalTradeltemldentificaton type it will be provided to the GUDID as a secondary DI The population of one of the additionalTradeltemldentificaton type values for an issuing agency will denote the appropriate issuing agency code value for GUDID for which the value populated in this attribute is relevant This attribute is required if a value is populated for additionalTradeltemldentificaton type Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of
18. devices in premarket commercial submission distribution number regardless of pre market authorization requirements per 21 CFR 807 28 f GMDN Code Unique Enter all Can edit add or 1 Required Numeric 5 GMDN list numerical five applicable delete after digit code used GMDN Preferred Grace Period to generically Term Codes identify medical devices and related health care products Name Name System N A 1 1 Alphanumeric GMDN list associated with populated based Required the GMDN on GMDN Preferred Term Preferred Term Code Code Definition Description System N A 1 1 Alphanumeric GMDN list associated with populated based Required the GMDN on GMDN Preferred Term Preferred Term Code Code Device Characteristics For Single Use Indicates that the Choose a value Cannot edit after 1 1 N A Yes No device is from the drop Grace Period Required intended for one down useorona single patient during a single procedure Production Identi fier s on Label Issue 1 Apr 2014 All contents copyright GS1 Page 25 of 163 Lot or Batch Number Flag to indicate the device is managed by lot or batch number This number can be found on the device label or packaging Lot or Batch means one finished device or more that consist of a single type model class size composition or software version that are manufactured under essentially the same conditions and
19. in UDI The Global Location Number is a 13 digit numeric GS1 standard used to identify locations and legal entities While the U S FDA UDI regulation does not require the use of GLNs in order to comply with the rule it is required when using the Global Data Synchronisation Network GDSN to identify the manufacturer and the data recipients In addition the U S FDA Global UDI database is identified by GLN 1100001017041 within the GDS Network This unique identification ensures that there is a single and unique global identification of the U S FDA GUDID within the entire GDS Network for all Data Pools to use in the submission and registration of the manufacturer s medical device product data GDSN Knowledge This guide and the information contained within it require the reader to have a basic understanding of the Global Data Synchronisation Network GDSN For more information on the GDSN refer to the GDSN page on the GS1 website or contact a GS1_ member Organisation or a GDSN certified Data Pool Issue 1 Apr 2014 All contents copyright GS1 Page 6 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 1 4 What is UDI and G UDID The Unique Device Identifier UDI is a multinational initiative driven by several medical device regulators with the intention of improving patient safety and healthcare business processes Each UDI regulation is expected to include a database which will contain me
20. ocean transportation without wheels attached and is lifted on and off a ship Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TBE Tube Tube A cylindrical container sealed on one end that could be closed with a cap or dispenser on the other end Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TBN Tote Bin Tote Bin Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TKR Tank Car Tank Car Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code TKT Tank Truck Tank Truck Issue 1 Apr 2014 All contents copyright GS1 Page 89 of 163 FDA GUDID Attribute Code Value Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifi
21. or encircles the package container to secure and maintain unit integrity Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BDL Bundle Bundle Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BEM Beam Beam Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BIC Bing Chest Bing Chest Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BIN Bin Bin Issue 1 Apr 2014 All contents copyright GS1 Page 65 of 163 FDA GUDID Attribute Code Value GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description Definition where needed Packaging Type GDSN utilizes the Packaging Type Code BLK Bulk Bulk code value however GUDID currently needs a term for the code The term in the description field at right
22. that are intended to have uniform characteristics and quality within specified limits Choose a value from the drop down Can edit after Grace Period GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 1 1 Required Boolean Yes No Manufacturing Date Flag to indicate the device is managed by date of manufacture the date a specific device was manufactured Choose a value from the drop down Can edit after Grace Period 1 1 Required Boolean Yes No Serial Number Flag to indicate the device is managed by serial number This number can be found on the device label or packaging The serial number is Choose a value from the drop down Can edit after Grace Period 1 1 Required Boolean Yes No Issue 1 Apr 2014 All contents copyright GS1 Page 26 of 163 assigned by the labeler and should be specific to each device GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Expiration Date Flag to indicate Choose a value Can edit after 1 1 Boolean Yes No the device is from the drop Grace Period Required managed by down expiration date the date by which the label of a device states that the device must or should be used Latex Information Device required Indicates that the Choose a value Cannot edit after 1 1 Boolean Yes No to be l
23. the description field at right should be passed to the FDA GUDID Packaging Type Code WRP Wrapped Wrapped The process of enclosing all or part of an item with layers of flexible wrapping material e g for an individually packed ice cream Does not include items which are shrink wrapped or vacuum packed Prescription Use Rx Prescription Use Rx Consumer Sales Conditions PRESCRIPTION_REQU IRED Trade item may only be sold or dispensed under the direction of a rescription Secondary DI Issuing Agency ICCBA Secondary DI Issuing Agency GS1 Additional Trade Item Not needed as there can only be one Identification Type GTIN for an item and therefore cannot be a secondary GTIN Secondary DI Issuing Agency HIBCC Additional Trade Item Health Industry Business Identification Type Communication Barcode An alphanumeric identification number used as a common identifier within the healthcare industry across different locations In the Netherlands this code is managed by the European Health Industry Business Secondary DI Issuing Agency HIBCC Additional Trade Item Identification Type HIBC Health Industry Business Communication Barcode An alphanumeric identification number used as a common identifier within the healthcare industry across different locations In the Netherlands this code is managed by the European Health Industry Business Secondary DI Issuing Agency ICCBBA
24. 10 10 boxes in a carton 0061414111111 BASE_UNT_OR_EAG N A N A 1 Box of Gloves This is converted to the following for population in the GUDID Package DI Number pee Contains DI Package 1061414111111 4 0061414111111c Indicates there are 4 eaches in the pack 2061414111111 5 3061414111111 Indicates there are 5 packs in the case 3061414111111 10 0061414111111 Indicates there are 10 eaches in the pack 4061414111111 2 3061414111111 c Indicates there are 2 packs in the case Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be deleted Contains DI Package FDA GUDID Description The primary DI for the base package or any lower level package configuration contained within a given package configuration For example Package DI 201 and Package Dl 202 contain the base package Case with primary DI 101 Package DI 301 contains lower level package configuration of a Carton with Package Dl 201 Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Can add with new package configuration after Grace Period but cannot delete Required 0 Required if Package Configuration is entered Data Type amp Length Alphanumeric 6 23 depending on Issuing Agency Issue 1 Apr 2014 All contents copyright GS1 Page 124 of 163 GDSN for the FDA
25. Configurations entered prior to the end of the Grace Period EAN UCC numbering structures will be used for the identification of trade items All of them will be considered as 14 digit Global Trade Item Number GTIN Must be present to enable data to be presented to trade item catalogue Must be submitted by the owner of the data who may be the original manufacturer the importer the broker or the agent of the original manufacturer This field is mandatory within the Global Data Synchronization work process FDA GUDID contains the lowest level of the GDSN hierarchy as its primary Higher levels of packaging are only referenced as package levels See additional guidance below for more details totalQuantityOfNextLowerLevelTradelte Numeri M umeric This represents the Total quantity of next lower level trade items that this trade Issue 1 Apr 2014 All contents copyright GS1 Page 36 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN Definition GDSN Notes item contains A particular Global trade item Number a numerical value used to uniquely identify a trade item A trade item is any trade item trade item or service upon which there is a need to retrieve pre defined information and that may be planned priced ordered delivered and or invoiced at any point in any suppl
26. Data Flow This section is specific to the U S FDA GUDID as it is the first UDI database This section will be updated as other regulators introduce UDI regulation Options for registering data in the FDA GUDID 1 Manual data entry via the Web based tool This refers to a web portal provided by the U S FDA to register data directly in their GUDI The portal provides a means for the medical device manufacturer to enter and update their data manually directly in their database Issue 1 Apr 2014 All contents copyright GS1 Page 10 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 2 Bulk data registration direct from a manufacturer s internal application using the HL7 standard This refers to a machine to machine automated method of registering data It requires the use of the Standard Product Labelling standard from HL7 This provides the means for a manufacturer to register data directly from an internal application such as an ERP to the GUDID The manufacturer must convert their internal data record into the HL7 SPL standard 3 GDSN certified Data Pools can register data on behalf of the manufacturers using the HL7 Structured Product Labeling SPL standard The manufacturer will need list their data pool as their data provider when they create their Labeler profile with the FDA GS1 successfully tested this capability with 8 manufacturers with the support of 1Worldsync and GHX
27. Enter the name of the device Only the and symbols will be supported for the production release Cannot edit after Grace Period GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 1 1 Required Alphanumeric and symbols 80 N A Version or Model Number The version or model number found on the device label or accompanying packaging used to identify a category or design of a device The version or model means all devices that have specifications performance Enter an alphanumeric value Cannot edit after Grace Period 1 1 Required Alphanumeric and symbols 40 N A Issue 1 Apr 2014 All contents copyright GS1 Page 16 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide sale See 21 CFR 807 3 b for exceptions The device may or may not still be available for purchase in the mm dd yyyy size and composition within limits set by labeler Catalog The catalog Enter an Can edit add or 0 1 Alphanumeric N A Number reference or alphanumeric delete after Not Required and symbols product number value No Grace Period 40 found on the symbols are device label or accepted accompanying packaging to identify a particular roduct Device Additional Enter device Can edit add or 0 1 Not Alphanumeric N
28. Entry Notes Check box if DI record is for the combination product itself Do not check if the product is a constituent part of a combination product Webtool Edit Rules After Grace Period Cannot add or delete after Grace Period Required 0 1 Not Required Data Type amp Length Boolean Entry List of Values LOV N A New DI Trigger YES Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment groupedProduct value populated in GDSN is COMBINATION Definition Code representing if the trade item is considered by the manufacturer to be more than a single item such as a kit combination item Data Type Text GDSN Required Optional Final Deployment Attribute Name groupedProduct value populated in GDSN is COMBINATION Definition Code representing if the trade item is considered by the manufacturer to be more than a single item such as a kit combination item Data Type Code List GDSN Required OPTIONAL Population Guidance belwo This attribute has a temporary attribute AVP in GDSN groupedProduct It will be deployed into the GDSN Schema in 2016 17 into a final solution The GDSN attribute groupedProduct is a code list attribute It is used to specify if an item is a kit or a combination product A value populated for the GDSN attribute groupedProduct of COMBINATION will populate a value of TRUE for the GUDID attribute Combination Product Any other value or when no value is pr
29. Initial Sterilization Prior to Use PERACETIC_ACID A chemical in the organic peroxide family It is a bright colorless liquid with a characteristic acrid acetic acid type odor It has a strong oxidizing potential is highly corrosive and can explode at temperatures exceeding 110 C Sterilization Method Ultraviolet Light Initial Manufacture Sterilization Initial Sterilization Prior to Use UV_light Useful for sterilization of surfaces and some transparent objects Many objects that are transparent to visible light absorb UV UV irradiation is routinely Issue 1 Apr 2014 All contents copyright GS1 Page 95 of 163 FDA GUDID Attribute Code Value Sterilization Method Chlorine Dioxide GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description Definition where needed used to sterilize the interiors of biological safety cabinets between uses Storage and Handling Type Environment Temperature Storage GDSN Attributes Storage and Handling Storage and Handling Type Storage Storage and Handling storageEnvironmentAtm Environment GDSN Attributes osphericPressureMaxim Atmospheric um Pressure Storage and Handling Type Storage Storage and Handling storageEnvironmentAtm Environment GDSN Attributes osphericPressureMinimu Atmospheric m Pressure Storage and Handling Type Stora
30. NO Public Private Status Public GS1 GDSN Attribute Name LOGICAL POPULATION Logical value based on the attribute single or pair chosen to be populated for the device The list of applicable attributes are Current Attributes Attribute Name a storageHandlingTemperatureMaximum b storageHandlingHumidityMaximum c transportationMaximumTemperature Definition a The maximum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value b The maximum humidity in percentages that the goods should be stored in c The maximum temperature that a trade item can be held at during transport as defined by the manufacturer without affecting product safety or quality Temporary Attributes Attribute Name a storageEnvironmentAtmosphericPressureMaximum b transportationEnvironmentAtmosphericPressMaximum c transportationMaximumHumidityMaximum Definition a The maximum atmospheric pressure in which the item should be stored to remain usable This value is the value above which the trade item should not be subjected b The maximum atmospheric pressure in which the item should be transported to remain usable This value is the value above which the trade item should not be subjected c The maximum humidity in percentages in which the trade items should be transported Data Type Measurement GDSN Required OPTIONAL Population Guidance below The GDSN attributes are pairs of attri
31. Organisation htto Avww gs1 org contact Issue 1 Apr 2014 All contents copyright GS1 Page 163 of 163
32. Pieces Pieces Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PIR Pirns Pirns Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PKG Package Package Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PLC Primary Lift Primary Lift Container The largest Container outermost unitized package or articles secured together that can be handled usually mechanically in common shop floor warehouse applications as a single entity primary indicates preferred or mandatory Issue 1 Apr 2014 All contents copyright GS1 Page 83 of 163 Packaging Type FDA GUDID Attribute Code Value GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Packaging Type Code Code Value PLF Description where needed Platform Defin
33. Please polymer microparticles in an use this new wording when populating the aqueous medium attribute Indication of the food packageMarksFreeFrom Code List ingredients that the package is Use value of FREE_FROM_LATEX marked free from Prescription Status Use value of A code depicting restrictions PRESCRIPTION REQUIRED imposed on the Trade Item ConsumerSalesCondition Text 1 35 characters regarding how it can be sold to the consumer for example Prescription Required Use value of OTC MRI Safety Status Issue 1 Apr 2014 All contents copyright GS1 Page 44 of 163 FDA GUDID Data Element GS1 GDSN Attribute Name mRICompatibility GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GDSN Data Type Code List GDSN Definition This is an identification of the compatibility of a trade item for use in the presence of a Magnetic Resonance Imaging MRI system GDSN Notes Clinically Relevant Size ClinicalSizeType Code List The qualifier to denote the dimensional size which is Clinically relevant for the use of the trade item by the clinical user For example needle gauge for a 16 gauge needle or volume for a 200 cc syringe AVP clinicalSizeType clinicalSizeValue UoM Numeric Code List The value to denote the dimensional size which is clinically relevant for the use of the trade item by the cl
34. SHK Shook Shook Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code SHT Sheet Sheet A thin layer of material usually used as a pad for extra protection by isolating separating tiers or layers of parts within the package Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code SKD Skid Skid Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code SKE Skid elevating or lift truck Skid elevating or lift truck Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code SLP Slip Sheet Slip Sheet Shipping containers utilizing slip sheets which are cardboard platforms used to hold product for storage or transportation Issue 1 Apr 2014 All contents copyright GS1 Page 87 of 163 FDA GUDID Attribute Code Value Packaging Type GDSN utilizes the code value however
35. The bar is widely used in descriptions Type Unit of Measure Recommendation 20 pressure of pressure 1 bar 100 kilopascals 0 987 atmospheres UoM Storage and Handling Pending UoM UN CEL Degree Celsius Celsius also historically known as Type Unit of Measure Recommendation 20 centigrade is a temperature scale the freezing point of water is 0 degrees Celsius C and the boiling point 100 C at standard atmospheric pressure placing the boiling and freezing points of water exactly 100 degrees apart UoM Storage and Handling Pending UoM UN D5 Kilogram per A kilogram force per square Type Unit of Measure Recommendation 20 square centimetre centimeter kgf cm2 often just kilogram per square centimeter kg cm2 or kilopond per square centimeter is a unit of pressure using Issue 1 Apr 2014 All contents copyright GS1 Page 59 of 163 FDA GUDID Attribute Code Value GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition metric units Its use is now deprecated it is not a part of the International System of Units SI the modern metric system The unit is similar to the English unit psi lbf in2 UoM Storage and Handling Type Unit of Measure UoM Storage and Handling Pending Pending UoM UN Recommendation 20 UoM UN FAH FP Degree Fahrenhei
36. The term in the description field at right should be passed to the FDA GUDID Packaging Type Code DSK Packaging Type Code DTB Double length Skid Double length Tote Bin Double length Skid Double length Tote Bin Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code DUF Packaging Type Code EGG Duffelbag Egg Crating Duffelbag Egg Crating In containers and shipping devices usually describes a type of interior dunnage which allows the contents to be individually segregated horizontally and vertically to provide protection during transportation and storage Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in Packaging Type Code ENV Envelope Envelope A predominantly flat container of flexible material having only two faces and joined at three edges to form an enclosure The non joined edge provides a filling Issue 1 Apr 2014 All contents copyright GS1 Page 74 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID
37. UN UZ Fifty Count Recommendation 20 UoM Pending UoM UN V2 Pouch Recommendation 20 UoM Pending UoM UN X_CHD Centisimal A count of attenuation steps or Recommendation 20 Hahnemannian dilution levels representing the Dilution CH homeopathic potency of a substance using the Hahnemannian CH method of attenuation commonly denoted as CH1 CH2 CH3 etc Issue 1 Apr 2014 All contents copyright GS1 Page 102 of 163 FDA GUDID Attribute Code Value GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition Each centesimal attenuation step represents one part source material combined with 99 parts dilution medium commonly denoted as C1 C2 C3 etc UoM Pending UoM UN X_KVN Recommendation 20 Korsakovian K A count of attenuation steps or dilution levels representing the homeopathic potency of a substance using the Korsakovian K method of attenuation commonly denoted as CK1 CK2 CK3 etc Each centesimal attenuation step represents one part source material combined with 99 parts dilution medium commonly denoted as C1 C2 C3 etc UoM UoM Pending Pending UoM UN X_MLM Recommendation 20 UoM UN X_MTC Recommendation 20 Millesimai LM Mother tincture Dry material A count of attenuation steps or dilution levels representing the home
38. a unit of time equal to Recommendation 20 time 1 60th of an hour or 60 seconds UoM Pending UoM UN MLT Millilitre A millilitre is one thousandth of a litre Recommendation 20 0 001 UoM Pending UoM UN MMK Square millimetre A square millimetre is an area of a Recommendation 20 square whose sides are exactly 1 millimetre in length UoM Pending UoM UN MMQ Cubic millimetre A cubic millimetre is the volume of a Recommendation 20 cube of side length one milliimetre 0 001 m UoM Pending UoM UN MON Month Unit of time equal to 1 12 of a year of Recommendation 20 365 25 days UoM Pending UoM UN MTK Square metre A square metre is an area of a square Recommendation 20 whose sides are exactly 1 metre in length UoM Pending UoM UN MTQ Cubic metre A cubic metre is the volume of a cube Recommendation 20 of side length one metre Issue 1 Apr 2014 All contents copyright GS1 Page 56 of 163 G 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value Description Definition where needed UoM Pending UoM UN MWH Megawatt hour A unit of energy defining the total Recommendation 20 1000 kW h amount of bulk energy transferred or consumed UoM Pending UoM UN ONZ Ounce A unit of mass with several Recommendation 20 definitions the most commonly used of which are equal to approximat
39. changes the use of a different facility or establishment to manufacture process sterilize or package the device changes in manufacturing facilities methods or quality control procedures changes in sterilization procedures changes in packaging changes in the performance or design specifications circuits components ingredients principles of operation or physical layout of the device and extension of the expiration date of the device based on data obtained under a new or revised stability or sterility testing protocol that has not been approved by FDA If the protocol has been previously approved by FDA a supplement is not submitted but the change must be reported to FDA in the post approval periodic reports as described in the 814 39 b Data Type Text GDSN Required Optional Final Deployment Attribute Name fDASupplementNumber Definition Number associated with the regulatory decision regarding the applicant s legal right to market a medical device PMA Supplement After FDA has approved a PMA an applicant must submit a PMA supplement for review and approval by FDA before making any change affecting the safety or effectiveness of the device unless FDA has advised that an alternate type of submission is permitted for a particular change All changes must meet the requirements of the Quality System regulation Good Manufacturing Practices under 21 CFR Part 820 including the design control requirement under 820 30 Changes for which
40. constitution it cannot be handled without it The characteristics Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code GPP Peel Pack Peel Pack A package used for sterile products which may be torn open without touching the product inside Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code GPU Packed Unspecified Packed Unspecified Packaging of the product or products is currently not on the list Use this code when no suitable options are available and only while a Change Request is approved for the proper packaging type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code HPR Hamper Hamper Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code HPT Hopper Truck Hopper Truck Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The t
41. copyright GS1 Page 117 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 17 DPM DI Number FDA GUDID Description An identifier that is marked directly on the medical device and is different than the Primary DI Number only applicable to devices subject to Direct Marking requirements under 21 CFR 801 45 Data Entry Notes GS1 14 digit numeric value HIBCC 6 23 character alphanumeric value ICCBBA 10 or 16 character alphanumeric value Edit Rules After Grace Period Can edit add or delete after Grace Period Required 0 Required only if check box for DM DI Different from Primary DI Data Type amp Length Numeric or Alphanumeric 6 23 characters Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment directPartMarking Definition This is a number or marking placed directly on the medical device Data Type Text GDSN Required Optional Final Deployment Attribute Name Pair of attributes in combination additionalTradeltemldentificaton type additionalTradeltemIdentificaton value Definition a Type of the identification system that is being used as an alternative to the Global Trade Item Number b Alternative means to the Global Trade Item Number to identify a trade item Data Type a Code List Multiple Occurrence b Text Multiple Occurrence GDSN Required OPTIONAL however if one
42. following Required for submission HCT Ps types 510 k PMA PDP HDE BLA and NDA Supplement Number Enter all valid Can add after 0 1 Not Numeric 4 N A Number assigned by FDA Supplement Grace Period Required unless toa Numbers Do not but cannot Device contains supplemental enter any alpha delete or edit Supplement Not application for characters required if approval of a Device Exempt change ina from Premarket medical device Submission is with an approved selected Not PMA HDE or required for Kits PDP FDA Product Code Product Code Classification for Enter all Can edit add or 0 Required for Alpha 3 FDA Product Code list pre market applicable delete after all medical devices issued Product Codes Grace Period devices except by the FDA for Kits or IVDs three letter code BL premarket submission number Product Code Name System N A 1 1 Alphanumeric FDA Product Code list Name associated with populated Required with 360 Issue 1 Apr 2014 All contents copyright GS1 Page 24 of 163 FDA Listing GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA Listing Number Enter all Can add after 0 Required for Alphanumeric N A Number assigned by FDA applicable Listing Grace Period all medical 7 during Numbers but cannot devices except Registration and delete or edit for HCT Ps Kits Listing to all and IVDs BL
43. for the population of a FDA Product Code for the device This can be accomplished by the population of the code value 43 in the GDSN attribute additionalClassificationAgencyName The actual Product Code can then be populated using the associated value in the GDSN attribute additionalClassificationCategoryCode This set of attributes will also be used to populate several other pieces of information FDA Product Code FDA Premarket Submission Number and GMDN For supply chain use this set of attributes can also provide the UNSPSC codes for the device 34 Product Code Name FDA GUDID Description Name associated with the three letter Product Code Data Entry Notes System populated Edit Rules After Grace Period N A Issue 1 Apr 2014 All contents copyright GS1 Page 137 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Required 1 1 Required with Product Code Data Type amp Length Alphanumeric 360 Entry List of Values LOV FDA Product Code list New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name N A Definition N A Data Type N A GDSN Required N A Population Guidance below The FDA will automatically populate the GUDID with a value for this attribute based on the Product Code submitted 35 FDA Listing Number FDA GUDID Description Number assigned by FDA during Registration and Listing to all devices in commercial distribution regardless o
44. glob quantityofNextLow globalTradeitemNumber tradeltemUnitDescriptor alTradeltemNumber erLevelTradeltem 2061414111111 CASE 1061414111111c 5 5 cartons in a case 1061414111111 PACK_OR_INNER_PACK 0061414111111 4 4 boxes in a carton 0061414111111 BASE_UNIT_OR_EACH N A N A 1 Box of Gloves Hierarchy Number 2 z ChildTradeltem glo quantityofNextLo A a ae a emeden waruevchnechic er 4061414111111 CASE 3061414111111 2 2 cartons in a case 3061414111111 a i 0061414111111 10 10 boxes in a carton Issue 1 Apr 2014 All contents copyright GS1 Page 125 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide ChildTradeltem glo quantityofNextLo balTradeltemNumb werLevelTradelte er m globalTradeitemNumb tradeltemUnitDescripto er lf N A N A 1 Box of Gloves 0061414111111 i a de aia This is converted to the following for population in the GUDID Quantity per Package DI Number Contains DI Package package 1061414111111 c 4 0061414111111 Indicates there are 4 eaches in the pack 2061414111111 5 3061414111111 Indicates there are 5 packs in the case 3061414111111 10 0061414111111 Indicates there are 10 eaches in the pack 4061414111111 2 3061414111111 Indicates there are 2 packs in the case Once published a 7 day grace period begins During the grace period most attributes can be edit
45. identify a trade item s trade item on batch or lot Differs from Serial Number which is a manufacturer assigned code during the trade item on cycle to identify a unique trade item Is the package marked with isPackageMarkedWithManufactureDate Boolean the date upon which the trade item was manufactured hasBatchNumber Boolean AVP isPackageMarkedWithManufactureDate Issue il Apr 2014 All contents copyright GS1 Page 43 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN Definition GDSN Notes The location on the item or packaging of a serial number A serial number is a code numeric or alphanumeric assigned to an individual serialNumberLocationCode Text 1 35 characters instance of an entity for its lifetime for example a Microscope model AC 2 with serial number 1234568 and microscope model AC 2 with serial number 1234569 Indicates the type of packagingMarkedExpirationDateType Code List expiration date marked on the packaging Latex Information An indication that a trade item This definition is currently listed on the is made from or contains latex Global Data Dictionary but will be E which refers generically to a changed in a future GDSN release to the Se Nominen Coel Hki stable dispersion emulsion of definition and wording at this link
46. in retention of the contents Specifically the description field a narrow necked container as at right should be compared with a jar or wide mouth passed to the FDA container The c GUDID Packaging Type GDSN utilizes the Packaging Type Code BOX Box Box A non specific term used to refer code value however GUDID currently needs a term for the code The term in to a rigid three dimensional container with closed faces that completely enclose its contents and may be made out of any material Even Issue 1 Apr 2014 All contents copyright GS1 Page 66 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition though some boxes might be reused or become resealed they could also be disposa Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BRC Bracing Bracing Material or devices used to hold articles or sections of loads in position to prevent shifting during transportation Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field a
47. is populated the other must also be populated Population Guidance below This should only be populated if a there is a Direct Part Mark on the Device AND b the DI used in the Direct Part Mark is NOT the Primary DI This attribute has a temporary attribute AVP in GDSN directPartMarking It will be deployed into the GDSN Schema in 2016 17 into a final solution Population of the GDSN Attribute additionalTradeltemldentificaton type with a value of DIRECT_PART_MARKk will allow for the appropriate additionalTradeltemldentificaton value to be Issue 1 Apr 2014 All contents copyright GS1 Page 118 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide populated This attribute pair can be repeated for as many DPM Di s the item might have The value populated in the GDSN attribute additionalTradeltemldentificaton type attribute associated with the additionalTradeltemldentificaton value DIRECT_PART_MARK is what will be populated in the GUDID This group attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Version or Model Number Catalog Number Secondary DI Number and FDA Listing Number 18 Secondary DI Issuing Agency FDA GUDID Description Name of Secondary DI Issuing agency Data Entry Notes Choose from drop down Webtool Edit Rules After Grace Period Cannot edit add o
48. issuing agency code value for GUDID This attribute is required if a value is populated for additionalTradeltem Identificaton value Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited Issue 1 Apr 2014 All contents copyright GS1 Page 119 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide This group attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Version or Model Number Catalog Number Secondary DI Number and FDA Listing Number Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 19 Secondary DI Number FDA GUDID Description An identifier that is an alternate secondary lookup for a medical device that is issued from a different issuing agency than the primary DI Data Entry Notes GS1 14 digit numeric value HIBCC 6 23 character alphanumeric value ICCBBA 10 or 16 character alphanumeric value NHRIC 10 digit numeric value Edit Rules After Grace Period Cannot edit add or delete after Grace Period
49. lifecycle management process 1 Create Import or Receive The first step is the creation of the product data This may include gathering information related to the product specifications raw materials function regulatory requirements and sterilization among other areas The U S FDA GUDID includes a specific list of data requirements and data relationship based on the recommendation from the International Medical Device Regulators Forum IMDRF formerly known as the Global Harmonization Task Force plus additional information required by the U S FDA In this step the manufacturer should confirm the core attributes and match against data requirements of the UDI regulation Sections 3 and 4 of this document contain a listing of the GUDID data requirements and cross reference to GDSN attributes The U S FDA UDI rule and Users Guide supersedes any information found in this document and will always serve as the point of reference for U S FDA UDI requirements 2 Enrich and Validate This step refers to an internal process by which the data created in step one is completed with any missing data validated for compliance with specific requirements of the UDI regulation and approved This is a fundamental step in data quality management GS1 offers general data quality guidance and best practices based on industry experience including the GS1 Data Quality Protocol Below are a few basic steps to consider Completeness Is data missing which is need
50. placed on the packaging Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 45 Device labeled as Not made with natural rubber latex FDA GUDID Description Indicates that natural rubber latex was not used as materials in the manufacture of the medical product and container Only applicable to devices not subject to the requirements under 21 CFR 801 437 Issue 1 Apr 2014 All contents copyright GS1 Page 146 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Data Entry Notes Check box if appropriate Webtool Only applicable if the response to Device required to be labeled as containing natural rubber latex or dry natural rubber was No Edit Rules After Grace Period If selected Yes to Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 cannot add or delete check to this field If selected NO to Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 can add or delete check to this field Required 0 1 Not Required Data Type amp Length Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name packageMarksFreeFrom D
51. product safety or quality The minimum temperature that a trade item can be held below during transport as defined by the manufacturer without affecting product safety or quality GUDID Code for Storage Type Handling environment temperature GUDID Code for Storage Type Handling environment temperature consumerUsageStoragelnstructions Text 1 to 1000 characters All contents copyright GS1 Expresses in text the consumer storage and usage instructions of a product which are normally held on the label or accompanying the product This information may or may not be labelled on the pack Instructions may refer to a suggested storage temperature a specific storage requirement or a reference to environment or duration Examples include Refrigerate After Opening Page 48 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN Definition GDSN Notes Consume within 4 days Keep Out Of Direct Sunlight Store at an Ambient Temperature Store ina Clean Cool Dry Place Store Away From Sunlight Strong Odours and Chemicals Keep in a Clean Cool Dry and Odourless Place Away From Direct Sunlight and Freezing Temperatures Keep in a Clean Cool Dry and Odourless Place Away From Direct Sunlight Before opening store at 5 C 30 C After O
52. quantity GTIN of a unit of use as defined fDAUnitOfUseGTIN GTIN by the FDA This is a lower level AYP paunitOfUseGTIN unit which is contained in the Trade Item Identification of a party by use of This pair of attributes will be provided as additionalPartyldentificationType Code List a code other than the Global additional party identification for the Location Number Brand Owner GLN A party identifier that is in addition to the GLN additionalPartyldentificationValue Text The recognisable name used by a brand owner to uniquely identify a line of trade item or services This is recognizable by the consumer Type of the identification system A ao s that is being used as an additionalTradeltemldentificationType Code List alemaive a the Global Trade Use code value of MODEL_NUMBER Item Number Alternative means to the Global additionalTradeltemldentificationValue Text Trade Item Number to identify a trade item Type of the identification system that is being used as an Use code value of alternative to the Global Trade SUPPLIER_ASSIGNED Item Number Alternative means to the Global additionalTradeltemldentificationValue Text Trade Item Number to identify a trade item Text 1 to 35 brandName characters additionalTradeltemldentificationType Code List Issue 1 Apr 2014 All contents copyright GS1 Page 34 of 163 1 GDS
53. should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code BLT Belting Belting As pertains to containers and code value however shipping devices a method of GUDID currently securing the contents to the needs a term for the conveyance device or securing code The term in components of the shipping device to the description field each other using one or more bands at right should be of flexible material having high tensile passed to the FDA strength and GUDID S Ge gcc eee Packaging Type GDSN utilizes the Packaging Type Code BME Blister Pack Blister Pack A type of packaging in code value however which the item is secured between a GUDID currently preformed usually transparent needs a term for the plastic dome or bubble and a code The term in paperboard surface or carrier the description field Attachment may be by stapling heat at right should be sealing gluing or other means In passed to the FDA other instan GUDID Packaging Type GDSN utilizes the Packaging Type Code BOB Bobbin Bobbin code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code BOT Bottle Bottle A container having a round code value however neck of relatively smaller diameter GUDID currently than the body and an opening needs a term for the capable of holding a closure for code The term
54. the data elements are locked and can no longer be edited This group attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Version or Model Number Catalog Number Secondary DI Number and FDA Listing Number Issue 1 Apr 2014 All contents copyright GS1 Page 120 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 20 Package DI Number FDA GUDID Description A device identifier for the package configuration that contains multiple units of the base package does not include shipping containers For example 4 glove boxes in a Carton Package DI 201 the UDI on the Carton 5 Cartons in a Case Package DI 301 the UDI on the Case contains a 5 cartons with DI 201 with 4 glove boxes in a carton 10 glove boxes in a Carton Package Dl 202 the UDI on the Carton Data Entry Notes GS1 14 digit numeric value HIBCC 6 23 character alphanumeric value ICCBBA 10 or 16 character alphanumeric value Edit Rules After Grace Period Can add after Grace Period but cannot delete Required 0 Not Required Required if Package Configuration is entered
55. the outbound GUDID Message by the Data Pool Will use the value GS1 in all GDSN instances By using GDSN the GTIN of the lowest level of the hierarchy will become the Primary DI By using a GTIN as the Primary DI this will require the issuing agency to be GS1 Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be changed Many of the data elements are locked and can no longer be edited Primary DI FDA GUDID Description An identifier that is the main primary lookup for a medical device and meets the requirements to uniquely identify a device through its distribution and use The primary DI number will be located on the base package which is the lowest level of a medical device containing a full UDI Data Entry Notes GS1 14 digit numeric value HIBCC 6 23 character alphanumeric value ICCBBA 10 or 16 character alphanumeric value Edit Rules After Grace Period Cannot edit add or delete after Grace Period Issue 1 Apr 2014 All contents copyright GS1 Page 106 of 163 3 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Required 1 1 Required Data Type amp Length Numeric or Alphanumeric characters 6 23 characters Entry List of Values LOV N A New DI Trigger YES Public Private Status Public GS1 GDSN Attribute Name globalTradeltemNumber Definition A particul
56. to identify medical devices identifying different product variants and each package configuration to achieve unique and unambiguous identification The UDI includes at a minimum the static portion a Device Identifier DI as its key to specific device related information stored in a database The GTIN is the GS1 solution for creating the Device Identifier component of a UDI and accessing medical device information stored in a database The Unique Device Identifier also includes a dynamic portion known as the Production Identifier to represent production control information generated as part of the manufacturing process based upon Issue 1 Apr 2014 All contents copyright GS1 Page 5 of 163 1 3 3 1 3 4 1 3 5 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide the specific medical device This Production Identifier Pl can include for example manufacturing date expiry date lot number or serial number GS1 Application Identifiers Als are the GS1 solution for creating the Production Identifier component of a UDI Note the Production Identifier portion of a UDI is NOT stored in a UDI database Additional information regarding the use of the GS1 GTIN and Application Identifiers can be found in the GS1 General Specifications GS1 Healthcare GTIN Allocation Rules and GS1 UDI support materials http Awww gs1 org healthcare udi Automatic Identification and Dat
57. unit of the kallikrein inactivator UoM Pending UoM UN KO Milliequivalence A unit of count defining the number of Recommendation 20 caustic potash per milligrams of potassium hydroxide per gram of product gram of product as a measure of the concentration of potassium hydroxide in the product UoM Pending UoM UN LUX Lux Lux is the SI unit of illuminance and Recommendation 20 luminous emittance measuring luminous flux per unit area UoM Pending UoM UN MEQ mEq or Milliequivalents of solute per liter of Recommendation 20 milliequivalents solvent or milliNormal where mEq L mN This is especially common for measurement of compounds in biological fluids for instance the healthy level of potassium in the blood of a human is defined between 3 5 and 5 0 mEq L UoM Pending UoM UN MIU Million International A unit of count defining the number of Recommendation 20 Unit NIE international units in multiples of 106 UoM Pending UoM UN MX Mod Pallet Mixed Recommendation 20 UoM Pending UoM UN ON Ounces per square The weight of one square yard of the material expressed in ounces Commonly used to express the density or weight of all types of paper paperboard and fabric e g 20 OZ or 20 Weight denim has an area density Issue 1 Apr 2014 All contents copyright GS1 Page 101 of 163 FDA GUDID Attribute Code Value G 1 GS1 GDSN Attribute Code Value Description where needed GDSN for the FDA Global U
58. 57 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide For the GUDID the GDSN attributes with maximum in their name will map the numeric value into the GUDID attribute High Value The GDSN attributes with minimum in their name will map the numeric value into the GUDID attribute Low Value The following grid maps the GUDID code value for Storage Type to the applicable GDSN Attributes C10 B BRS OIT Code GDSN Attributes storageHandlingTemperatureMaximum Storage environment l ax storageHandlingTemperatureMinimum temperature storageHandlingHumidityMaximum Storage environment humidity storageHandlingHumidityMinimum Storage environment storageEnvironmentAtmosphericPressureMaximum atmospheric pressure storageEnvironmentAtmosphericPressureMinimum AVP Handling environment transportationMaximumTemperature temperature transportationMinimumTemperature i transportationMaximumHumidityMaximum Handling environment humidity transportationMaximumHumidityMinimum AVP Handling environment transportationEnvironmentAtmosphericPressMaximum atmospheric pressure transportationEnvironmentAtmosphericPressMinimum AVP Some devices have a temperature humidity or pressure range High Max and Low Min values Some have a greater than or less than value and others have a single or recommended value Population of all possibilities can be handled in the GDSN an
59. A Description relevant description Only delete after Required and symbols max 2000 information the and Grace Period 2000 characters about the device symbols will be that is not supported for the already captured production as a distinct release GUDID data attribute Commercial Distribution DI Record Indicates the Choose date Cannot edit add 1 1 Numeric date N A Publish Date date the DI from calendar or or delete after Required format 10 mm dd yyyy Record gets manually enter in Published published andis format available via mm dd yyyy Public Search Cannot edit during or after Grace Period Commercial Indicates the Choose date Can edit add or 0 1 Not Numeric date N A Distribution date the device from calendar or delete after Required format 10 End Date is no longer held manually enter in Grace Period mm dd yyyy or offered for format Issue 1 Apr 2014 All contents copyright GS1 Page 17 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide marketplace Commercial Indicates System N A 0 1 N A In Commercial Distribution Not in Distribution whether the populated Required if Commercial Distribution Status device is in record is commercial published distribution as defined under 21 CFR 807 3 b Alternative or Additional Identifiers Direct Marking DM Device Subject The device is Select checkbo
60. AtmosphericPressureMaximum b storageEnvironmentAtmosphericPressureMinimum c transportationEnvironmentAtmosphericPressMaximum d transportationEnvironmentAtmosphericPressMinimum e transportationMaximumHumidityMaximum f transportationMaximumHumidityMinimum Definition a The maximum atmospheric pressure in which the item should be stored to remain usable This value is the value above which the trade item should not be subjected b The minimum atmospheric pressure in which the item should be stored to remain usable This value is the value below which the trade item should not be subjected c The maximum atmospheric pressure in which the item should be transported to remain usable This value is the value above which the trade item should not be subjected d The minimum atmospheric pressure in which the item should be transported to remain usable This value is the value below which the trade item should not be subjected e The maximum humidity in percentages in which the trade items should be transported f The minimum humidity in percentages in which the trade items should be transported Data Type Measurement GDSN Required OPTIONAL Population Guidance below All contents copyright GS1 Page 155 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide The GDSN attributes are pairs of attributes with a minimum and a maximum value This provides a range of applicability for t
61. DA a supplement is not submitted but the change must be reported to FDA in the post approval periodic reports as described in the 814 39 b FDA Product Code Section 510 k of the Food Drug and Cosmetic Act requires device manufacturers who must register to notify FDA of their intent to market a medical device at least 90 days in advance This is known as Premarket Notification also called PMN or 510 k This allows FDA to determine whether the device is equivalent to a device already placed into one of the three additionalClassificationCategoryAgency Code List Use code 43 Issue 1 Apr 2014 All contents copyright GS1 Page 40 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN Definition GDSN Notes classification categories Specifically medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected Such change or modification could relate to the design material chemical composition energy source manufacturing process or intended use Category code based on alternate classification additionalClassificationCategoryCode Text 1 15 charact
62. DA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Packaging Type Code Code Value CAB Description where needed Cabinet Definition Cabinet Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code CAG CAN Cage Can Cage A container enclosed on at least one side by a grating of wires or bars that lets in air and light Can A metallic and generally cylindrical container of unspecified size which can be used for items of consumer and institutional sizes Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code CAR CAS Carrier Case Carrier Case A non specific term for a container designed to hold house and sheath or encase its content while prot
63. DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name LOGICAL POPULATION Logical value based on the attribute single or pair chosen to be populated for the device The list of applicable attributes are Current Attributes Attribute Name a storageHandlingTemperatureMaximum Issue 1 Apr 2014 All contents copyright GS1 Page 154 of 163 Issue 1 Apr 2014 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide b storageHandlingTemperatureMinimum c storageHandlingHumidityMaximum d storageHandlingHumidityMinimum e transportationMaximumTemperature f transportationMinimumTemperature Definition a The maximum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value b The minimum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value c The maximum humidity in percentages that the goods should be stored in d The minimum humidity in percentages that the goods should be stored in e The maximum temperature that a trade item can be held at during transport as defined by the manufacturer without affecting product safety or quality f The minimum temperature that a trade item can be held below during transport as defined by the manufacturer without affecting product safety or quality Temporary Attributes Attribute Name a storageEnvironment
64. DID Packaging Type Code KRK Knockdown Rack Knockdown Rack Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code KTB Knockdown Tote Bin Knockdown Tote Bin Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code LAB Label Tag Label Tag Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code LID Lip Top Lip Top In packaging the top or bottom of a container usually the part that closes the opening may also be known as cap over or top Issue 1 Apr 2014 All contents copyright GS1 Page 79 of 163 FDA GUDID Attribute Code Value Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Packaging Type Code Code Value LIF Description where needed Lifts Definition L
65. DID Description Company physical address associated with the DUNS Number entered in the DI This address should match the address on the device label Data Entry Notes System Populated Edit Rules After Grace Period Can be edited through D amp B only Required 1 1 Required Data Type amp Length Alphanumeric Entry List of Values LOV N A New DI Trigger N A Public Private Status Private GS1 GDSN Attribute Name N A Definition N A Data Type N A GDSN Required N A Population Guidance Below Issue 1 Apr 2014 All contents copyright GS1 Page 110 of 163 8 9 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide The FDA will populate this information into the GUDID based on information from D amp B based on the Labeler DUNS provided If the information is not correct D amp B should be contacted to facilitate correcting the data Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can only be changed with Dunn and Bradstreet D amp B Many of the data elements are locked and can no longer be edited Brand Name FDA GUDID Description The Proprietary Trade Brand name of the medical device as used in device labeling or in the catalog This information may 1 be on a label attached to a durable device 2 be ona package of a disposable device or 3 appear in labeling materials
66. EST_BEFORE_DATE Not Applicable Expiration Date Type Expiration Date TRUE Packaging Marked EXPIRY_DATE Not Applicable Expiration Date Type Expiration Date Other values or no Packaging Marked value populated Expiration Date Type equates to a value of FALSE FDA Premarket Submission GMDN Additional Classificaiton 35 GMDN Global Medical Devices Number Category Type Nomenclature GMDN FDA Product Code FDA Premarket Submission FDA Product Code Additional Classificaiton 43 FDA Product Code US FDA Product Code Classification Number Category Type Database The Product Classification FDA Product Code Database contains medical device names and associated information developed by the Center for Devices and Radiological Health CDRH in support of its mission This database contains For GDS Use Only Additional Classificaiton 5 UNSPSC UNSPSC United Nations Standard Category Type Products and Services Code For GDS Use Only Additional Classificaiton 6 UNSPSC ECCMA UNSPSC Electronic Commerce Category Type Code Management Association For Single Use FALSE Healthcare Trade Item LIMITED_REUSABLE Manufacturer has indicated that Reusability product may be reused but has provided special instructions limitations or guidelines around the reuse of this trade item For Single Use FALSE Healthcare Trade Item REUSABLE Product can be reused Reusability For Single Use TRUE Healthcare Trade Item REUSABLE_SAME_PA Product can only be reused for the Reusability TIENT sam
67. FALSE will be populated in the GUDID Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 58 Requires Sterilization Prior to Use FDA GUDID Description Indicates that the device requires sterilization prior to use Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Cannot edit after Grace Period Required 1 1 Required Data Type amp Length Boolean Entry List of Values LOV Yes No New DI Trigger YES Public Private Status Public GS1 GDSN Attribute Name LOGICAL POPULATION Logical BOOLEAN value of TRUE from the population of any value in initialSterilisationPriorT oUse Definition N A Data Type N A GDSN Required OPTIONAL Population Guidance below The GDSN attribute initialSterilirilizationPriorToUse is a code list indicating the type s of sterilization which should be performed on a device prior to use Population of a value for this attribute signifies that the device is not sterile and that the Provider does need to sterilize it prior to use using the method populated If a code value is published in the GDSN then a value of TRUE will be populated in the GUDID If no value is published in GDSN then a value of FALSE will be populated in the GUDID Once published a 7 day grace
68. For lengths Centimeter Cubic Inch Measure measure from the drop Grace Period Required if Size Decimeter Feet Femtometer French Inch associated with down but cannot is provided Kilometer Meter Microliter Micrometer Issue 1 Apr 2014 each clinically relevant size delete or edit All contents copyright GS1 Millimeter Nanometer Picometer Pint Square Centimeter Square Feet Square Inch Square Meter Square Millimeter Ton Yard For Total Volume Centiliter Cup Deciliter Femtoliter Fluid Ounce Gallon Kiloliter Liter Micrograms per Total Volume Milligrams per Total Volume Milliliter Nanoliter Picoliter Quart Units per liter Page 30 of 163 Size Type Text Additional undefined device size not represented in the GUDID Clinically relevant size list Enter size type text in addition to units uuraCce Can add after Grace Period but cannot delete or edit GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 0 Not Required singin Alphanumeric including symbols 200 Storage and Handling Storage and Indicates storage Choose a value Can edit add or 0 Not Required N A Handling Environment Atmospheric Handling Type and handling from the drop delete after Required if Pressure Handling Environment Humidity requirements down Grace Period Storage and Handling Environ
69. G b additionalTradeltemldentificaton value Definition a Type of the identification system that is being used as an alternative to the Global Trade Item Number b Alternative means to the Global Trade Item Number to identify a trade item Data Type a Code List Multiple Occurrence b Text Multiple Occurrence GDSN Required OPTIONAL however if one of the pair is populated the other must be populated Population Guidance below This attribute has a temporary attribute AVP in GDSN fDAMedicalDeviceListingNumber It will be deployed into the GDSN Schema in 2016 17 into a final solution The GUDID is asking for the FPD Medical Device Listing number assigned to the device This repeatable set of attributes will allow for the population of a FDA Medical Device Listing Number for the device This can be accomplished by the population of the code value FDA_MEDICAL_DEVICE_LISTING in the GDSN attribute additionalPartyldentification type The actual FDA Medical Device Listing can then populated in the GUDID using the associated additionalPartyldentification value s This group attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Version or Model Number Catalog Number Secondary DI Number and FDA Listing Number Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace perio
70. GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Packaging Type Code COR Description where needed Core Definition Core Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CRD Packaging Type Code CRF Cradle Corner Reinforcement Cradle Corner Reinforcement Usually in boxes or crates additional material or components attached to adjacent panels to add support or prevent crushing or separation Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CRT Packaging Type Code CSK Crate Cask Crate A non specific term usually referring to a rigid three dimensional container with semi closed faces that enclose its contents for shipment or storage Crates could have an open or
71. Global Unique Device Identifier Database GUDID Implementation Guide Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name ChildTradeltem globalTradeltemNumber Definition A particular Global trade item Number a numerical value used to uniquely identify a trade item A trade item is any trade item trade item or service upon which there is a need to retrieve pre defined information and that may be planned priced ordered delivered and or invoiced at any point in any supply chain Identifier 14 digits DEPENDENT Data Type GDSN Required Population Guidance below The GUDID Package attributes are populated as a group and can not be entered as single elements in the message These attributes are Package DI Number Quantity per Package Contains DI Package Package Type Package Discontinue Date All packages must be entered If a new package level is created it is to be added to the GUDID as part of the Primary DI to which it is applicable This GDSN attribute references the quantity of the child trade item GUDID Contains DI Package which is contained in the GTIN GUDID Package DI Number See the example below This GDSN attribute references the hierarchy level which is the next level below or Child of the globalTradeitemNumber GUDID Package DI Number See the example below In GDSN the following is provided Hierarchy Number 1 ChildTradeltem
72. HDE BLA and NDA Data Entry Notes Enter all valid FDA Premarket Submission Numbers Edit Rules After Grace Period Can add after Grace Period but cannot delete or edit Required 1 Required Not required if Device Exempt from Premarket Submission is selected Not required for Kits Required for HCT Ps Data Type amp Length Alphanumeric 8 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment fDA510KPremarketAuthorization Definition Premarket approval PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class Ill medical devices These values are the 510K Premarket Authorization Numbers assigned to the item Data Type Text GDSN Required Optional Final Deployment Attribute Name Pair of attributes in combination a additionalClassificationAgencyName Code for FDA_510K_PREMARKET_NOTIFICATION b additionalClassificationCategoryCode Definition Issue 1 Apr 2014 All contents copyright GS1 Page 134 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide a Text name of the additional external classification agency whose schema is being provided in addition to the Global EAN UCC schema Required if additional classification schema fields are populated b Category code based on alternate classification schema chosen in addition to EAN UCC classi
73. ID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PRT Partitioning Partitioning The proceeds of applying separators or dividers Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PUN Punnet Punnet Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PWT Plastic Wrapped Tray Plastic Wrapped Tray Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code RAL Rail Semiconductor Rail Semiconductor Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description
74. IFIED or MRI_UNSAFE is published in the GDSN attribute mRICompatibility By using GDSN the GTIN of the lowest level of the hierarchy will become the Primary DI Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can only be changed to a value of TRUE from a value of FALSE If the value needs to be changed to a value of FALSE from a value of TRUE a new UDI will be required Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be added but can not be deleted 49 MRI Safety Status FDA GUDID Description Indicates the MR safety status of the device The three drop down values are MR Safe MR Conditional and MR Unsafe Please see the ASTM F2503 13 standard for more information on these three values Data Entry Notes Must select one value from drop down if selected check box for Has the device been evaluated for MRI Safety Webtool Edit Rules After Grace Period Can add MRI Safety Status after Grace Period only if the field Has the device been evaluated for MRI Safety was previously unchecked Cannot edit after Grace Period if Has the device been evaluated for MRI Safety was previously checked Required 1 Required if selected check box for Is the device labeled for MRI Safety
75. International Medical Device Regulators Forum IMDRF to align as much of their requirements as possible However each regulator will probably have a specific and distinct set of data requirements This means that manufacturers will need to maintain separate data records for each UDI regulators database Additionally they will need to establish separate connections or methods of registering their product data in the particular UDI database The GDSN provides a means for any manufacturer of any size to provide data to all UDI databases and their customers hospitals distributors wholesalers GPOs simultaneously with a single connection Below are the high level steps of the data flow from the manufacturer to the GUDID when using a GDSN Data Pool 1 The manufacturer prepares data required by the Global UDI Database 2 The manufacturer provides GUDID data to their GDSN Data Pool of choice 3 The GDSN Data Pool converts the data provided by the manufacturer to the HL7 SPL format refer to the GUDID User Manual for information 4 The GDSN Data Pool registers the manufacturer s product data using the HL7 SPL format in the GUDID 5 The GDSN Data Pool confirms the registration with the Manufacturer once a confirmation from the GUDID is received by the GDSN Data Pool The GDSN provides a secure and easy way for manufacturers to register their product data with any UDI database anywhere in the world via a single connection Refer to the GDSN we
76. Issue 1 Apr 2014 All contents copyright GS1 Page 149 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Data Type amp Length N A Entry List of Values LOV MR Safe MR Unsafe MR Conditional New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name mRICompatibility Definition This is an identification of the compatibility of a trade item for use in the presence of a Magnetic Resonance Imaging MRI system Data Type Code List GDSN Required OPTIONAL Population Guidance below This GDSN attribute is a code list of values signifying if the device is safe for use in an MRI environment All GDSN code values map to an applicable GUDID code value While it is not recommended to use a GDSN value of UNSPECIFIED as this provides no useful information and can lead to confusion in a Clinical setting However if a GDSN value of UNSPECIFIED is published this will be mapped to MR Unsafe as a default Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be edited but only under certain circumstances See Edit Rules After Grace Period for more details 50 Size Type FDA GUDID Description Dimension type for the clinically relevant measurement of the medical device Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Can add after Grace Perio
77. Its use is archaic having been replaced by the SI unit of energy the joule However in many countries it remains in common use as a unit of food energy In the context of nutrition and especially food labelling the calorie is approximately equal to 4 1868 joules J and energy values are normally quoted in kilojoules kJ and kilocalories kcal UoM Pending UoM UN DO Dollars U S Recommendation 20 UoM Pending UoM UN DR Drum Recommendation 20 UoM Pending UoM UN DRA Dram US The dram archaic spelling drachm Recommendation 20 was historically both a coin anda weight Currently it is both a small mass in the Apothecaries system of weights and a small unit of volume Issue 1 Apr 2014 All contents copyright GS1 Page 99 of 163 FDA GUDID Attribute Code Value G 1 GS1 GDSN Attribute GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Code Value Description where needed Definition This unit is called more correctly fluid dram or in contraction also fluidram The term also refers to the fluid dram a measure of capacity equal 18 of a fluid ounce which means it is exactly equal to 3 696 691 195 312 5 mL in the United States UoM Pending UoM UN DRI Dram UK The dram archaic spelling drachm Recommendation 20 was historically both a coin and a weight Currently it is both a small mass in the Apothecaries
78. Minimum Some devices have a temperature humidity or pressure range High Max and Low Min values Some have a greater than or less than value and other have a single or recommended value Population of all possibilities can be handled in the GDSN and the GUDID using the following chart Range of Lowest to Highest Minimum or Low Values Field Lowest Value Maximum or High Values Field Highest Value Less Than a Value Minimum or Low Values Field Leave Null provide no value Maximum or High Values Field Highest Value Greater Than a Value Minimum or Low Values Field Lowest Value Maximum or High Values Field_ Leave Null provide no value Single or Recommended Value Minimum or Low Values Field Single Same Value populated in both fields Maximum or High Values Field 56 Special Storage Conditions FDA GUDID Description Indicates any special storage requirements for the product Data Entry Notes Can enter alphanumeric with symbols Edit Rules After Grace Period Can edit add or delete after Grace Period Required 0 Not Required Required if Special Storage Condition Text selected Data Type amp Length Alphanumeric 1 200 Characters Entry List of Values LOV New DI Trigger NO Issue 1 Apr 2014 All contents copyright GS1 Page 160 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Public Private Status Public GS1 GDSN Attribute Name consume
79. N for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN Definition GDSN Notes Additional variants necessary to communicate to the industry to help define the product Multiple variants can be established for each GTIN This is a repeatable field e g Style Colour and CONCATENATION Fragrance The schema uses tradeltemDescription and common library component as additionalTradeltemDescription shown in the GDD Max Size field For the business requirements for item please use the specific definition of this data type and field 1 350 Text 1 to 350 additionalTradeltemDescription characters An understandable and useable description of a trade item using brand and other descriptors This Text 1 to 178 attribute is filled with as little characters abbreviation as possible while keeping to a reasonable length Free form text field this data element is repeatable CONCATENATION tradeltemDescription and additionalTradeltemDescription tradeltemDescription Commercial Distribution The date on which the information contents of the master data version are valid Valid correct or true This effective date can be used for initial trade item offering or to mark a change in the in formation related to an existing trade item This date would mark when these changes take effect Da
80. N for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description Definition where needed Packaging Type GDSN utilizes the Packaging Type Code AMP Ampoule Ampoule A relatively small container code value however made from glass or plastic tubing the GUDID currently end of which is drawn into a stem and needs a term for the closed by fusion after filling The code The term in bottom may be flat convex or drawn the description field out An ampule is opened by at right should be breaking the stem passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code AT Atomizer Atomizer A device for reducing a code value however liquid to a fine spray e g medicine GUDID currently perfume etc An atomizer does not needs a term for the rely on a pressurised container for the code The term in propellant Usually air is provided by the description field squeezing a rubber bulb attached to at right should be the atomizer passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code ATH Attachment Attachment In containers and code value however shipping devices a component that GUDID currently can be added to provide additional needs a term for the functionality or security as required by code The term in the contents or method of the description field transportation handling at right should be passed to the FDA GUDID Pack
81. Package attributes are populated as a group and can not be entered as single elements in the message These attributes are Package DI Number Quantity per Package Contains DI Package Package Type Package Discontinue Date All packages must be entered If a new package level is created it is to be added to the GUDID as part of the Primary DI to which it is applicable This GDSN attribute references the quantity of the child trade item GUDID Contains DI Package which is contained in the GTIN GUDID Package DI Number See the example below In GDSN the following is provided Hierarchy Number 1 ChildTradeltem gl quantityofNextL obalTradeltemNu owerLevelTradel ber Or mber tem 2061414111111c CASE 1061414111111c 5 5 cartons in a case 1061414111111c PACK_OR_INNER_PA CK 0061414111111c 4 4 boxes in a carton Issue 1 Apr 2014 All contents copyright GS1 Page 123 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide ChildTradeltem gl quantityofNextL obalTradeltemNu owerLevelTradel mber tem globalTradeitemNum tradeltemUnitDescrip ber tor BASE_UNIT_OR_EAC 0061414111111c H N A N A 1 Box of Gloves Hierarchy Number 2 globalTradeitemNum tradeltemUnitDescrip Soi Come oud GENAL obalTradeltemNu owerLevelTradel Notes ber tor mber tem 4061414111111 c CASE 3061414111111 2 2 cartons in a case 3061414111111 ia id 0061414111111
82. Primary DI is set to Not in Commercial Distribution the Package Status will also be set to Not in Commercial Distribution 25 Support Contact Phone FDA GUDID Description Phone number for the support contact Data Entry Notes Enter 10 digit North American number For international numbers start with Does not require the use of or but can enter these symbols Edit Rules After Grace Period Can edit add or delete after Grace Period Required 1 Required if support contact information is entered Data Type amp Length Numeric 20 10 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name Pair of attributes in combination a contactType b communicationChannelCode c communicationNumber Definition a The general category of the contact party for a trade item for example Purchasing Issue 1 Apr 2014 All contents copyright GS1 Page 128 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide b Means used to communicate with another party c Number assigned to a specific means of communication Data Type a Code List b Code List Multiple Occurrence c Text 1 70 characters Multiple Occurrence GDSN Required OPTIONAL however if any of the three is provided an instance of all three are required Population Guidance below The GDSN attribute contactType signifies which type of contact i
83. RFT ROL Reinforcement Roll Reinforcement In containers and shipping devices a component usually temporary added to a container for a particular application to lend additional support under severe applications Roll Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code RVR SAK Reverse Reel Sack Reverse Reel Sack Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in Packaging Type Code SCS Suitcase Suitcase Issue 1 Apr 2014 All contents copyright GS1 Page 86 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code
84. Required 1 1 Required Data Type amp Length N A Entry List of Values LOV Yes No New DI Trigger YES Public Private Status Public Issue 1 Apr 2014 All contents copyright GS1 Page 141 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Name manufacturerDeclaredReusabilityT ype Definition Determines if the product is intended for single or multiple uses including the number of validated cycles and the number of times a product can be used according to the manufacturer specifications It is suggested that medical providers consult the device manufacturer s Instruction For Use IFU for full reusability instructions Data Type Code List GDSN Required OPTIONAL Population Guidance below This attribute is a code list stating if the item can be used again When a value of SINGLE_USE or REUSABLE_SAME_PATIENT are populated for the GDSN attribute manufacturerDeclaredReusabilityType the GUDID will be populated with a value of TRUE signifying the device is intended for one use or on a single For all other values populated in the GDSN attribute manufacturerDeclaredReusabilityType the GUDID will be populated with a value of FALSE signifying the device can be used more than one time Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be change
85. Size Unit of Measure For example for a 16 gauge needle the value is 16 and the UoM is H79 for a 20 cc syringe the value is 20 and the UoM is CQM This attribute is part of a repeatable class of clinical attributes for the device containing the Size Type Size Value and Size Unit of Measure for the device s clinical size Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be added but can not be edited or deleted 52 Size Unit of Measure FDA GUDID Description The unit of measure associated with each clinically relevant size Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Can add after Grace Period but cannot delete or edit Required 1 Required if Size is provided Data Type amp Length Code List Entry List of Values LOV UCUM list of allowable values New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment clinicalSizeUoM Issue 1 Apr 2014 All contents copyright GS1 Page 152 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition The value to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user For example 16 gauge for a needle or 200 cc for a syringe Carries a UoM from the Recommendation 20 code list
86. U Candela per Square Meter Anti XA Unit Candela per Square Meter is the SI base unit of luminous intensity that is power emitted by a light source in a particular direction weighted by the luminosity function in square meters This is also known as nit in some markets A unit of measure for blood potency Units for the anti XA activity which is a measure to the anti coagulating effect at low molecular heparins UoM Pending UoM UN Recommendation 20 AXU Anti XA Unit International Units A unit of measure for blood potency International units for the anti XA activity which is a measure to the anti coagulating effect at low molecular heparins A unit of measure for blood potency UoM Pending UoM UN Recommendation 20 B10 Bit per second In telecommunications and computing bitrate sometimes written bit rate data rate or as a variable R or fb is the number of bits that are conveyed or processed per unit of time The bit rate is quantified using the bits per second bit s or bps unit Issue 1 Apr 2014 All contents copyright GS1 Page 97 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Recommendation 20 FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value Description Definition where needed UoM Pending UoM UN B60 Lumens per Recommenda
87. Water 750ml net content 750 MLT 20 count pack of diapers net content 20 ea In case of multi pack indicates the net content of the total trade item For fixed value trade items use the value claimed on the package to avoid variable fill rate issue that arises with some Issue 1 Apr 2014 All contents copyright GS1 Page 107 of 163 4 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide trade item which are sold by volume or weight and whose actual content may vary slightly from batch to batch In case of variable quantity trade items indicates the average quantity Data Type Numeric Code List GDSN Required N A Population Guidance below The net content attribute is a measurement attribute which is a number and a corresponding qualifier representing the unit of measure UoM The unit of measure code values are from the United Nations Recommendation 20 Code List UN Rec 20 For GDSN net content is required when the attribute is trade item a consumer unit is populated with a value of TRUE This attribute refers to if an item is the unit of end consumption It is important to note that if the Device Count is greater than 1 gt 1 then a Unit of Use DI is required to be provided in the GUDID Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data ele
88. a Capture AIDC Marking Marking of the UDI on the medical device packaging and in some cases the medical device itself via an Automatic Identification and Data Capture AIDC Data Carrier technology is a primary requirement of the U S FDA UDI ruling The Data Carrier is the means used to transport the UDI with the medical device and retrieve its unique identification enabling access to the database stored information The GS1 System includes specifications for the use of both Bar Code and RFID Data Carriers including but not limited to EAN UPC GS1 128 GS1 DataMatrix Bar Code symbologies GS1 DataMatrix EAN 13 UPC A ais GS 1 128 we x UOMO DO TNT 3 906 oE eA 01 10857674002017 10 1152KMB 17 141120 10 1234AB 4 512345 678 Selection of the appropriate GS1 Data Carrier is based upon a number of factors including the UDI to be encoded in the Data Carrier the distribution channel of the medical device available space for the Data Carrier among other criteria of the regulation Additional information and specifications on the selection and use of GS1 Data Carriers can be found in the GS1 General Specifications and GS1 UDI support materials http Awww gs1 org healthcare udi For additional information on identification of items below the each level refer to the GS1 Healthcare GTIN Allocation Rules http Awww gs1 org 1 gtinrules index php p static t healthcare The role of Global Location Number GLN
89. a RAND license to Necessary Claims as that term is defined in the GS1 IP Policy Furthermore attention is drawn to the possibility that an implementation of one or more features of this Specification may be the subject of a patent or other intellectual property right that does not involve a Necessary Claim Any such patent or other intellectual property right is not subject to the licensing obligations of GS1 Moreover the agreement to grant licenses provided under the GS1 IP Policy does not include IP rights and any claims of third parties who were not participants in the Work Group Accordingly GS1 recommends that any organization developing an implementation designed to be in conformance with this Specification should determine whether there are any patents that may encompass a specific implementation that the organization is developing in compliance with the Specification and whether a license under a patent or other intellectual property right is needed Such a determination of a need for licensing should be made in view of the details of the specific system designed by the organization in consultation with their own patent counsel THIS DOCUMENT IS PROVIDED AS IS WITH NO WARRANTIES WHATSOEVER INCLUDING ANY WARRANTY OF MERCHANTABILITY NONINFRINGMENT FITNESS FOR PARTICULAR PURPOSE OR ANY WARRANTY OTHER WISE ARISING OUT OF THIS SPECIFICATION GS1 disclaims all liability for any damages arising from use or misuse of this Standard whether spe
90. abeled as device or from the drop Grace Period Required containing packaging down natural rubber contains natural latex or dry rubber that natural rubber contacts humans 21 CFR as described 801 437 under 21 CFR 801 437 Choosing yes indicates that the device label or packaging contains one of the following statements 1 Caution This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions 2 This Product Contains Dry Natural Rubber 3 Caution The Packaging of This Product Issue 1 Apr 2014 All contents copyright GS1 Page 27 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Contains Natural Rubber Latex Which May Cause Allergic Reactions or 4 The Packaging of This Product Contains Dry Natural Rubber Device labeled as Not made with natural rubber latex Indicates that natural rubber latex was not used as materials in the manufacture of the medical product and container Only applicable to devices not subject to the requirements under 21 CFR 801 437 Check box if appropriate Only applicable if the response to Device required to be labeled as containing natural rubber latex or dry natural rubber was No If selected Yes to Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 cannot add or delete check
91. act communicationChannelCode Code List with another party email is EMAIL Number assigned to a communicationNumber Text 1 70 characters specific means of communication Device Status The trade item has as a component or ingredient human tissue The amount of AVP tissue is not limited to a does TradeltemContainHumanTissue certain amount any amount will cause a flag of TRUE doesTradeltemContainHumanTissue Boolean Code representing if the trade S item is considered by the AMP groupeclPirecwet KM groupedProduct Code List manufacturer to be more than a single item such as a kit combination item AVP groupedProduct COMBINATION Premarket Device is exempt from FDA Premarket regulations Premarket approval PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class Ill medical devices Class III AVP devices are those that support or sustain human life are of substantial importance in preventing impairment of human health or which present a potential unreasonable risk of illness or injury Due to the level of risk associated with Class Ill devices FDA has determined exemptFromFDAPreMarketAuthorization External Code managed by FDA exemptFromFDAPreMarketAuthorizatio Boolean n Issue 1 Apr 2014 All contents copyright GS1 Page 38 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementa
92. aging any material inserted between tiers or layers of articles to prevent contact and provide protection Shrink Wrap In packaging a plastic film around an item or group of items which is heated causing the film to shrink securing the unit integrity The use of shrunken film to tightly wrap a package or a unit load in order to bind protect and immobilize Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in Packaging Type Code STW Stretch Wrap Stretch Wrap In packaging a high tensile plastic film stretched and wrapped repeatedly around an item or group of items to secure and maintain unit integrity The use of stretch film Issue 1 Apr 2014 All contents copyright GS1 Page 88 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description Definition where needed to tightly wrap a package or a unit load in order to bind protect a Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code SV2 SEAVAN SEAVAN A commercial or government owned or leased shipping container which is moved via
93. aging Type GDSN utilizes the Packaging Type Code BAG Bag Bag A preformed flexible container code value however generally enclosed on all but one GUDID currently side which forms an opening that needs a term for the may or may not be sealed after filling code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code BAL Bale Bale code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code BBL Barrel Barrel A cylindrical packaging whose code value however GUDID currently needs a term for the code The term in bottom end is permanently fixed to the body and top end head is either removable or non removable Issue 1 Apr 2014 All contents copyright GS1 Page 64 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description Definition where needed Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BDG Banding Banding Something that binds ties
94. alue of TRUE when there is any amount of human tissue as part of the device Otherwise the value should default to FALSE 28 Kit FDA GUDID Description Indicates that the device is a convenience combination in vitro diagnostic IVD or medical procedure kit Kits are a collection of products including medical devices that are packaged together to achieve a common intended use and is being distributed as a medical device Data Entry Notes Check box if DI record is for the kit itself Do not check if the product is part of a kit Webtool Edit Rules After Grace Period Cannot add or delete after Grace Period Required 0 1 Not Required Data Type amp Length Boolean Entry List of Values LOV N A New DI Trigger YES Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment groupedProduct value populated in GDSN is KIT Definition Code representing if the trade item is considered by the manufacturer to be more than a single item such as a kit combination item Data Type Text GDSN Required Optional Final Deployment Attribute Name groupedProduct value populated in GDSN is KIT Definition Code representing if the trade item is considered by the manufacturer to be more than a single item such as a kit combination item Data Type Code List GDSN Required OPTIONAL Population Guidance below This attribute has a temporary attribute AVP in GDSN groupedProduct It will be depl
95. amp Length Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public Issue 1 Apr 2014 All contents copyright GS1 Page 147 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Name ConsumerSalesCondition Definition A code depicting restrictions imposed on the Trade Item regarding how it can be sold to the consumer for example Prescription Required Data Type Code List GDSN Required OPTIONAL Population Guidance below This GDSN attribute is a code list of values signifying how the item is presented for sale to a consumer If a value of PRESCRIPTION _REQUIRED is published in the GDSN attribute ConsumerSalesCondition attribute a value of TRUE will be populate in the GUDID Any other code value published in GDSN will populate a value of FALSE for this GUDID attribute 47 Over the Counter OTC FDA GUDID Description Indicates that the device does not require a prescription to use and can be purchased over the counter OTC Data Entry Notes Select check box if appropriate Webtool Edit Rules After Grace Period Can add or delete after Grace Period Required 0 1 Not Required Data Type amp Length Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name ConsumerSalesCondition Definition A code depicting restrictions imposed on the Trade Ite
96. an applicant must submit a PMA supplement include but are not limited to the following types of changes if they affect the safety or effectiveness of the device new indication for use of the device labeling changes the use of a different facility or establishment to manufacture process sterilize or package the device changes in manufacturing facilities methods or quality control procedures changes in sterilization procedures changes in packaging changes in the performance or design specifications circuits components ingredients principles of operation or physical layout of the device and extension of the expiration date of the device based on data obtained under a new or revised stability or sterility testing protocol that has not been approved by FDA If the protocol has been previously approved by FDA a supplement is not submitted but the change must be reported to FDA in the post approval periodic reports as described in the 814 39 b Data Type Integer GDSN Required OPTIONAL Population Guidance This attribute has a temporary attribute AVP in GDSN fDASupplementNumber It will be deployed into the GDSN Schema in 2016 17 into a final solution This is the FDA identification number associated to the regulatory decision regarding the applicant s legal right to market a medical device PMA Supplement Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace peri
97. an identification number which defines the configuration of the product in addition to the Item number This is typically printed or otherwise attached to an item In electronics this number is typically found around or near a serial number Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be changed Many of the data elements are locked and can no longer be edited 10 Catalog Number FDA GUDID Description The catalog reference or product number found on the device label or accompanying packaging to identify a particular product Data Entry Notes Enter an alphanumeric value No symbols are accepted Edit Rules After Grace Period Can edit after Grace Period Required 0 1 Not Required Issue 1 Apr 2014 All contents copyright GS1 Page 112 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Data Type amp Length Alphanumeric and symbols 40 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name Pair of attributes in combination a additionalTradeltemldentificaton type b additionalTradeltemldentificaton value Definition a Type of the identification system that is being used as an alternative to the Global Trade Item Number b Alternative means to the Global Trade Item Number to identify a trade item Data Type a Co
98. ar Global trade item Number a numerical value used to uniquely identify a trade item A trade item is any trade item trade item or service upon which there is a need to retrieve pre defined information and that may be planned priced ordered delivered and or invoiced at any point in any supply chain Data Type Identifier 14 digits GDSN Required MANDATORY Population Guidance below This is one of the key elements in GDSN and is required for the use of GDSN By using GDSN to provide data to the GUDID the GTIN will always be the Primary DI All other issuing agency identification will be published as secondary Once published a 7 day grace period begins During the grace period most attribute can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited Device Count FDA GUDID Description Number of medical devices in the base package For example Base Package Box of 100 gloves Primary DI 101 Device Count 100 Data Entry Notes Enter a numeric value Edit Rules After Grace Period Cannot edit add or delete after Grace Period Required 1 1 Required Data Type amp Length Numeric 7 Entry List of Values LOV N A New DI Trigger YES Public Private Status Public GS1 GDSN Attribute Name Net Content amp UoM Definition The amount of the trade item contained by a package usually as claimed on the label For example
99. art is equal to 1 32 of a Recommendation 20 US bushel exactly 1 101220942715 litres UoM Pending UoM UN QTL Liquid quart US A US liquid quart exactly equals 57 75 Recommendation 20 cubic inches which is exactly equal to 0 946352946 litres UoM Pending UoM UN SEC Second unit of A second is a unit of time equal to Recommendation 20 time 1 60th of an minute UoM Pending UoM UN STN Ton US or short Ton US 2000 Lb or 907 Kg Recommendation 20 ton UK UoM Pending UoM UN SX Shipment A unit of count defining the number of Recommendation 20 shipments shipment an amount of goods shipped or transported Issue 1 Apr 2014 All contents copyright GS1 Page 57 of 163 FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value Description where needed GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition UoM Pending UoM UN TNE Tonne Metric ton 1000 Kg Recommendation 20 UoM Pending UoM UN U2 Tablet A unit of count defining the number of Recommendation 20 tablets tablet a small flat or compressed solid object UoM Pending UoM UN WEE Week A week is a time unit equal to seven Recommendation 20 days UoM Pending UoM UN WHR Watt hour The watt hour is a unit of energy Recommendation 20 equivalent to one watt of power expended for one hour of time it is equal to 3 6 kilojo
100. ase in 2016 into the attribute tradeltemDateOnPackagingTypeCode This GUDID attribute is a Boolean clarifying how the item is controlled It is not for the population of actual expiration dates Neither the GUDID nor GDSN are used to provide actual expiration dates These should be communicated in transactional documents such as packaging shipping and invoice documents A value populated of BEST_BEFORE_DATE or EXPIRY_DATE for the current GDSN attribute packagingMarkedExpirationDateType or of BEST_BEFORE_DATE or EXPIRATION_DATE for the attribute tradeltemDateOnPackagingTypeCode signifies that the item has as one of its controls an expiration date It also signifies that the expiration date will be printed on the packaging and in the UDI Issue 1 Apr 2014 All contents copyright GS1 Page 145 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 44 Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 FDA GUDID Description Indicates that the device or packaging contains natural rubber that contacts humans as described under 21 CFR 801 437 Choosing yes indicates that the device label or packaging contains one of the following statements 1 Caution This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions 2 This Product Contains Dry Natural Rubber 3 Caution The Packaging of This Produ
101. asure Pending Pending GS1 GDSN Attribute UoM UN Recommendation 20 UoM UN Recommendation 20 Code Value X_SPS 4H Description where needed Sample per second Micrometre GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition A unit of count defining the number of samplings takes during a period of time A micrometre is one millionth of a metre also termed Micron UoM Size Unit of Measure Pending UoM UN Recommendation 20 H79 French gauge The French scale most correctly abbreviated as Fr but also often abbreviated as FR or F is commonly used to measure the catheter size Circumference is in millimeters in which 1 Fr 0 33 mm in diameter In the French Gauge system as it is also known the diameter in millimeters of the catheter can be determined by dividing the French size by 3 thus an increasing French size corresponds with a larger diameter catheter The following equations summarize the relationships D mm Fr 3 or Fr D mm 3 UoM Size Unit of Measure Pending UoM UN Recommendation 20 PNT Point A single unit on a scale of measurement as part of an incentive program or pricing structure used as a means of making a quantitative evaluation UoM Storage and Handling Type Unit of Measure Pending UoM UN Recommendation 20 80 Pound per square inch Absolute Psia pound force per square inc
102. ated to corporate versus division autonomy and perhaps even legal incorporation of the various divisions which make up the organization There are many models for establishing and documenting Roles and Responsibilities The first step should be to determine if your organization has a corporate philosophy or policy for assigning roles and responsibilities for information lifecycle management If not a basic place to start might be the RACI model R Responsible owns the project problem or task The person responsible for doing the work to achieve the task A to whom the R is Accountable who must sign off approve work before it is effective C to be Consulted has information and or capability necessary to complete the work a lz to be Informed must be notified of results need not be consulted This simple yet effective model can be applied in any size company In large organizations which include divisions in various parts of the world the roles and responsibilities are usually managed in decentralized manner Conversely in a small organisation everyone involved in the information management supply chain may be located in a single location The level of specificity depends on the granularity needed in order for the Master Data Management and Governance process to be effective and for it to meet its intended purpose For the purpose of UDI regulation the internal Regulatory Affairs function should be consulted as well GDSN
103. between 20 and 100 mg kg Device labeled as Not made with FALSE packageMarksFreeFrom WITHOUT_ADDED_SU The item is physically marked that no natural rubber latex GAR sugar has been added when manufacturing the product but it still can contain sugars that are naturally part of the ingredients as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom WITHOUT_ADDED_SW The item is physically marked that no natural rubber latex EETENER sweetener has been added when manufacturing the product as approved by the appropriate authority of the target market Device required to be labeled as FALSE Does Trade Item Contain FALSE The Brand Owner labeling does not containing natural rubber latex or dry natural rubber 21 CFR Latex state the Trade Item contains latex or may state that the Trade Item is free Issue 1 Apr 2014 All contents copyright GS1 Page 61 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value Description Definition where needed 801 437 from latex Device required to be labeled as TRUE Does Trade Item Contain TRUE Brand Owner labeling states the containing natural rubber latex or Latex Trade Item contains latex dry natural rubber 21 CFR 801 437 Expiration Date TRUE Packaging Marked B
104. bsite for a list of GDSN certified Data Pools http www gs1 org gdsn GUDID Data Requirements The Device Identifier DI is the primary key in the UDI database and will be linked to other product data elements Manufacturers will be responsible for submitting and maintaining their own data in the Issue 1 Apr 2014 All contents copyright GS1 Page 12 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide database The U S FDA Global UDI Database GUDID will not contain the Production Identifiers i e Expiration Date Batch Lot Number Serial Number or others The core elements are the minimum elements needed to identify a medical device through distribution and use Regional or National UDID may contain additional elements however these additional elements should be kept to a minimum International Medical Device Regulators Forum IMDRF UDI System for Medical Devices The Global Unique Device Identification Database GUDID has a set of attributes for population of information about a medical device These attributes are of various types Boolean Code List Text etc and if it is Required or Not Required The specifics of each attribute varies based upon the information requested by the attribute s definition and the type of device being described The table below provides a list of the GUDID attributes and their particulars as current at the time of the creation of this d
105. bute Name GDSN Data Type GDSN Definition GDSN Notes any process that effectively kills or eliminates transmissible agents such as fungi bacteria viruses prions and spore forms etc from a surface equipment foods medications or biological culture medium Some methods of sterilisation are through the application of heat radiation and ethylene 5 FDA GUDID mapping to GS1 code values The list below are FDA GUDID code values mapped to GS1 GDSN Code values For some of these attributes there may be additional code values available for use in GDSN not listed This list focuses on just the values applicable to the GUDID mapping Where the terming PENDING is utilized it means actual code values have either not been identified by the FDA or that a code is in process with the Global Standards Management Process GSMP but not yet assigned FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value Description Definition where needed Version or Model Number Additional Trade Item MODEL _ NUMBER Current definition Additional Vendor Identification Type identification number which defines the configuration of the product over and above the Item number Definition for GDSN Major Release 3 x in 2016 The additional Trade Item Identification value populated is an identification number which defines the configuration of the product in addition to the Item number This is typically printed or otherwise at
106. butes with a minimum and a maximum value This provides a range of applicability for the device for that temperature humidity pressure pair The applicable storage type can be derived from the attribute name For the GUDID the GDSN attributes with maximum in their name will map the numeric value into the GUDID attribute High Value The GDSN attributes with minimum in their name will map the numeric value into the GUDID attribute Low Value Issue 1 Apr 2014 All contents copyright GS1 Page 159 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide The following grid maps the GUDID code value for Storage Type to the applicable GDSN Attributes GUDID Storage Type Code ie Attributes Storage environment temperature storageHandlingTemperatureMaximum storageHandlingTemperatureMinimum Storage environment humidity storageHandlingHumidityMaximum storageHandlingHumidityMinimum Storage environment atmospheric storageEnvironmentAtmosphericPressureMaximum AVP pressure storageEnvironmentAtmosphericPressureMinimum Handling environment transportationMaximumTemperature temperature transportationMininumTemperature Handling environment humidity transportationMaximumHumidityMaximum AVP transportationMaximumHumidityMinimum Handling environment transportationEnvironmentAtmosphericPressMaximum AVP atmospheric pressure transportationEnvironmentAtmosphericPress
107. case for which the data is intended such as UDI regulation 7 Purge Generally speaking outdated information should be deleted from systems where it has been stored as part of the publication process This should include the generation of a Purge List which should be provided to the internal data owners and users some cases this may include the approval of the purge by the data owner The U S FDA UDI rule includes specific requirements regarding the information lifecycle management which may supersede guidance found in this document For additional information refer to the U S FDA GUDID User s Guide Data Governance Data governance relates to an enterprise wide process which includes decision authority policy and issue escalation An enterprise wide Data Governance process should include data management data quality data policies and risk management and executive sponsorship The process should ensure that certain data assets are formally recognized and managed throughout the organization Data Governance is a critical component of Master Data Management and especially important to the accuracy of the data requirements of a UDI regulation Each manufacturer is responsible for submitting and maintaining their data in the UDI database Issue 1 Apr 2014 All contents copyright GS1 Page 9 of 163 1 9 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Data Governance should include the deci
108. cation Date effectiveDate in GDSN then the Commercial Distribution Status will be set to In Commercial Distribution automatically by the FDA If the current date is equal to or greater than the GUDID Commercial Distribution End Date lastShipDate in GDSN then the Commercial Distribution Status will be set to Not in Commercial Distribution automatically by the FDA 15 Device Subject to Direct Marking DM but Exempt FDA GUDID Description The device is exempt from Direct Marking requirements under 21 CFR 801 45 Data Entry Notes Select checkbox if appropriate Webtool Edit Rules After Grace Period Can add or delete after Grace Period Required O 1 Not Required Data Type amp Length Boolean Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment isTradeltemExemptFromDirectPartMarking Issue 1 Apr 2014 All contents copyright GS1 Page 116 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition Indicator signifying the trade item is exempt from direct identification marking according to regulation or regulatory filings within the target market Data Type Boolean GDSN Required Optional Final Deployment Attribute Name isTradeltemExemptFromDirectPartMarking Definition Indicator signifying the trade item is exempt from direct identification marking according to regulation o
109. cationChannelCode c communicationNumber Definition a The general category of the contact party for a trade item for example Purchasing b Means used to communicate with another party Issue 1 Apr 2014 All contents copyright GS1 Page 129 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide c Number assigned to a specific means of communication Data Type a Code List b Code List Multiple Occurrence c Text 1 70 characters Multiple Occurrence GDSN Required OPTIONAL however if any of the three is provided an instance of all three are required Population Guidance belwo The GDSN attribute contactType signifies which type of contact information is being provided For end user or consumer support the code value should be CONSUMER_SUPPORT For the item s regulatory contact information the code value should be LICENSEE_REGISTRAR The GDSN attributes communicationChannelCode and communicationNumber can repeat as a pair of attributes for a single contactType There can be more than one contactType populated for a single Trade item For the GUDID the contactType of CONSUMER_SUPPORT will signify the information to be provided to the GUDID via GDSN Where an instance of the GDSN attribute communicationChannelCode is populated with the value of EMAIL the corresponding communicationNumber will map to the GUDID attribute Support Contact Email Where an insta
110. ce This can be accomplished by the population of the code value 35 in the GDSN attribute additionalClassificationAgencyName The actual GMDN Code can then be populated using the associated value in the GDSN attribute additionalClassificationCategoryCode Only the GMDN Code will be populated in the GUDID This set of attributes will also be used to populate several other pieces of information FDA Product Code FDA Premarket Submission Number and GMDN For supply chain use this set of attributes can also provide the UNSPSC codes for the device The population of a GMDN Code via GDSN has been available for some time While the FDA will not make the code available to the Public in the GUDID GDSN will pass the code along to normal GDSN recipients for their use following their existing processes 37 Name FDA GUDID Description Name associated with the GMDN Preferred Term Code Data Entry Notes System populated based on GMDN Preferred Term Code Edit Rules After Grace Period N A Required 1 1 Required Data Type amp Length Alphanumeric Entry List of Values LOV GMDN New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name additionalClassificationCategoryDescription Definition In the additional classification system the description of the category Data Type Text 1 70 characters GDSN Required Optional Population Guidance below Issue 1 Apr 2014 All contents copyright GS1 Page 140 of 163 GDSN for
111. ceed 163 Issue 1 Apr 2014 All contents copyright GS1 Page 4 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 1 introduction 1 1 Purpose of this Document The purpose of this document is to explain how to use the Global Data Synchronization Network GDSN to securely provide data to a Unique Device Identification UDI database The first version of this implementation guide will focus on the U S FDA Global Unique Device Identifier Database GUDID requirements since this is the only regulator to issue a UDI rule for medical devices as of this writing As other regulators introduce UDI regulation this document will be updated as needed 1 2 Who Will Use this Document This document is intended primarily for medical device manufacturers who have decided to use GS1 standards to comply with UDI regulation and the GDSN Data Pools who will be required by the medical device customers to provide data on their behalf to a UDI database The guidance and GDSN attributes included in this document is based on the published database requirements and GUDID Users Guide from the U S FDA plus the lessons learnt from the GDSN pilot held as part of the U S FDA User Acceptance testing of 2012 This document contains addition guidance on Master Data Management and Governance plus Information Lifecycle Management and Data Quality This information is intended as general guidance for the purpose of assi
112. cial indirect consequential or compensatory damages and including liability for infringement of any intellectual property rights relating to use of information in or reliance upon this document Issue 1 Apr 2014 All contents copyright GS1 Page 2 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 retains the right to make changes to this document at any time without notice GS1 makes no warranty for the use of this document and assumes no responsibility for any errors which may appear in the document nor does it make a commitment to update the information contained herein Issue 1 Apr 2014 All contents copyright GS1 Page 3 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Table of Contents 1 Introd CtOM sacs vs cccceite tes enmsewe cn iccacmnasenenese cetcantasacsntanecccesesinaseeimasccesewedssecasarececusecetnsenerasenmscunaaces 5 Li Purpose ofthis DOCUMENT sssrin a a a E AE A A thee 5 12 Who Will Use this DOCUMOENME siscosinsierinionansaentninninnakiaa aaa iana iaaa ana aa aa ia 5 tos PRONE QUISILC ce cecnctopsectccededstehl euhcnnetnenikesvhcrend dedtemervinlerendacheavtnnteamnnhiibanuseenddcbiishabevhne enebeiutags 5 1 3 1 The GS1 Global Company Prefix GCP cccceeceeeeeceeeeeeeaeeeeeeeceeeesaaeeeeaeeseneeeseaeeesaeeeeaeeee 5 1 3 2 Role the Global Trade Item Number GTIN and Application Identifiers Als
113. closed top and may have internal divers Even though some crates mig Cask Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in Packaging Type Code CTN Carton Carton A non specific term for a re closable container used mostly for perishable foods e g eggs fruit Issue 1 Apr 2014 All contents copyright GS1 Page 72 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CU Cup Cup A small bowl shaped container for beverages often with a handle Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CX2 CONEX CONEX A reusable container for shipment of cargo Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to th
114. ct Contains Natural Rubber Latex Which May Cause Allergic Reactions or 4 The Packaging of This Product Contains Dry Natural Rubber Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Cannot edit after Grace Period Required 1 1 Required Data Type amp Length Boolean Entry List of Values LOV Yes No New DI Trigger YES Public Private Status Public GS1 GDSN Attribute Name does TradeltemContainLatex Definition An indication that a trade item is made from or contains latex which refers generically to a stable dispersion emulsion of polymer microparticles in an aqueous medium Data Type Non Binary Logic GDSN Required OPTIONAL Population Guidance below This GDSN attribute is a Non Binary Logic Code List with the values of TRUE FALSE NOT_APPLICABLE and UNSPECIFIED For the US Target Market the only values which can be used are TRUE and FALSE for medical devices All other values should not be accepted for a GDSN Target Market value of 840 US Application of the value is based upon whether a mark exists on the packaging as to latex being contained in the device or its packaging If a mark is required to be on the package this attribute is populated with TRUE If no mark is required then this attribute is populated with FALSE This is based on the regulation which basically states that if there is latex present a label mark must be
115. ct is hung or attached for display Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CHE Cheeses Cheeses Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CHS Chest Chest Issue 1 Apr 2014 All contents copyright GS1 Page 69 of 163 FDA GUDID Attribute Code Value Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Packaging Type Code Code Value CLD Description where needed Car Load Rail Definition Car Load Rail Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging T
116. d Microwave Radiation Sterilization Method Sound Waves Sterilization Method Sterilization Method Hydrogen Peroxide Ozone GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Initial Manufacture Sterilization Initial Sterilization Prior to Use Initial Manufacture Sterilization Initial Sterilization Prior to Use Initial Manufacture Sterilization Initial Sterilization Prior to Use Code Value GAMMA_RADIATION HYDROGEN_PEROXID E OZONE where needed Definition carried out between 30 C and 60 C with relative humidity above 30 and a gas conc Gamma rays are very penetrating and are commonly used for sterilization of disposable medical equipment such as syringes needles cannulas and IV sets Gamma radiation requires bulky shielding for the safety of the operators they also require storage o Another chemical sterilizing agent It is relatively non toxic once diluted to low concentrations although a dangerous oxidizer at high concentrations and leaves no residue Is a method often times used in industrial settings to sterilize water and air as well as a disinfectant for surfaces It has the benefit of being able to oxidize most organic matter It is a toxic and unstable gas that must be produced on site so it is Sterilization Method Peracetic Acid Initial Manufacture Sterilization
117. d Data Type amp Length Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name serialNumberLocationCode Definition The location on the item or packaging of a serial number A serial number is a code numeric or alphanumeric assigned to an individual instance of an entity for its lifetime for example a Microscope model AC 2 with serial number 1234568 and microscope model AC 2 with serial number 1234569 Data Type Text 1 35 characters External Code List GDSN Required OPTIONAL Population Guidance below This GUDID attribute is a Boolean clarifying how the item is controlled It is not for the population of an actual serial number s Neither the GUDID nor GDSN are used to provide an actual serial numbers s These should be communicated in transactional documents such as packaging shipping and invoice documents A GUDID value of TRUE signifies that the item has as one of its controls a serial number s It also signifies that the manufacture date will be printed on the packaging and in the UDI This GDSN attribute is a code list attribute designating where the serial number can be found on the item or its packaging if present If a value is populated for the GDSN attribute of MARKED_ON_PACKAGING MARKED_ON_PACKAGING_INSERT or MARKED_ON_TRADE_ITEM it signifies that the item has as one of its controls a serial number and a value of TRUE w
118. d Many of the data elements are locked and can no longer be edited 40 Lot or Batch Number FDA GUDID Description Flag to indicate the device is managed by lot or batch number This number can be found on the device label or packaging Lot or Batch means one finished device or more that consist of a single type model class size composition or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Can edit after Grace Period Required 1 1 Required Data Type amp Length Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name hasBatchNumber Definition Indication whether the base trade item is batch or lot number requested by law not batch or lot number requested by law but batch or lot number allocated or not batch or lot number allocated A batch or lot number is a manufacturer assigned code used to identify a trade items trade item on batch or lot Differs from Serial Number which is a manufacturer assigned code during the trade item on cycle to identify a unique trade item Data Type Boolean GDSN Required OPTIONAL Population Guidance below Issue 1 Apr 2014 All contents copyright GS1 Page 142 of 163 GDSN for the FDA Global Unique Device Identifie
119. d but cannot delete or edit Required 0 Not Required Required if Size is provided Data Type amp Length N A Entry List of Values LOV Circumference Depth Device Size Text specify French Catheter Gauge Greatest Diameter Height Length Lumen Diameter Needle Gauge Second Greatest Diameter Third Greatest Diameter Total Volume Width New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment clinicalSizeType Definition The qualifier to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user For example needle gauge for a 16 gauge needle or volume for a 200 cc syringe Issue 1 Apr 2014 All contents copyright GS1 Page 150 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Data Type Code List GDSN Required OPTIONAL Final Deployment Attribute Name _clinicalSizeType Definition The qualifier to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user For example needle gauge for a 16 gauge needle or volume for a 200 cc syringe Data Type Code List GDSN Required OPTIONAL Population Guidance below This attribute has a temporary attribute AVP in GDSN clinicalSizeText It will be deployed into the GDSN Schema in 2016 17 into a final solution All of the clinical attributes can be repeated as a group when this
120. d ends on day 8 this attribute can be added but can not be edited or deleted 36 Code FDA GUDID Description Unique numerical five digit code used to generically identify medical devices and related health care products Data Entry Notes Enter all applicable GMDN Preferred Term Codes Edit Rules After Grace Period Can edit add or delete after Grace Period Required Required Data Type amp Length Numeric 5 Entry List of Values LOV GMDN list New DI Trigger NO Public Private Status Private GS1 GDSN Attribute Name Pair of attributes in combination a additionalClassificationAgencyName b additionalClassificationCategoryCode Issue 1 Apr 2014 All contents copyright GS1 Page 139 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition a Text name of the additional external classification agency whose schema is being provided in addition to the Global EAN UCC schema Required if additional classification schema fields are populated b Category code based on alternate classification schema chosen in addition to EAN UCC classification schema Data Type a Code List Multiple Occurrence b Text 1 35 characters Multiple Occurrence GDSN Required OPTIONAL however if one of the pair is populated the other must be populated Population Guidance below This repeatable set of attributes will allow for the population of a FDA Product Code for the devi
121. d the GUDID using the following chart Range of Lowest to Highest Minimum or Low Values Field Lowest Value Less Than a Value Minimum or Low Values Field Leave Null provide no value Maximum or High Values Field Highest Value Maximum or High Values Field Highest Value Greater Than a Value Minimum or Low Values Field Lowest Value Maximum or High Values Field Leave Null provide no value Single or Recommended Value Minimum or Low Values Field Single Same Value populated in both fields Maximum or High Values Field 55 High Value FDA GUDID Description Indicates storage and handling requirements that are required for the device including temperature humidity and atmospheric pressure Data Entry Notes Edit Rules After Grace Period Required provided Choose a value from the drop down Webtool Can edit add or delete after Grace Period 0 Not Required Required if Storage and Handling is Data Type amp Length Code List Issue 1 Apr 2014 All contents copyright GS1 Page 158 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Entry List of Values LOV CV for Storage Conditions Storage environment temperature Storage environment humidity Storage environment atmospheric pressure Handling environment temperature Handling environment humidity Handling environment atmospheric pressure New DI Trigger
122. day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be added but can not be edited or deleted 53 Size Type Text FDA GUDID Description Additional undefined device size not represented in the GUDID Clinically relevant size list Data Entry Notes Enter size type text in addition to units Edit Rules After Grace Period Can add after Grace Period but cannot delete or edit Required 0 Not Required Data Type amp Length Alphanumeric including symbols 1 200 characters Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment Issue 1 Apr 2014 All contents copyright GS1 Page 153 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide clinicalSizeText Definition When the clinicalSizeType is coded as other this is the text used to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user Data Type Text 1 200 characters GDSN Required OPTIONAL Final Deployment Attribute Name clinicalSizeText Definition When the clinicalSizeType is coded as other this is the text used to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user Data Type Text 1 200 characters GDSN Required OPTIONAL Population Guidance be
123. de List Multiple Occurrence b Text Multiple Occurrence GDSN Required OPTIONAL however if one of the pair is populated the other must be populated Population Guidance below The GUDID is asking for a Model Number for the device This can be accomplished by the population of the code value SUPPLIER_ASSIGNED in the GDSN attribute additionalPartyldentification type The actual Model Number can then be populated in the GUDID using the associated additionalPartyldentification value s The code value of SUPPLIER_ASSIGNED is defined as Definition for GDSN Major Release 3 x in 2016 The additional Trade Item Identification value populated has been developed and assigned by the party which provides service s and or manufactures or otherwise has possession of the goods and consigns or makes them available in trade This number is a base model or style number assigned to the product and may be the same for several GTINs where they are variations of each other For example a coffee mug with 3 GTINs one each for the brown mug the white mug and the black mug might all be the supplier assigned number of AB123 Use of this value is recommended in the absence of a Model Number or Manufacturer s Part Number 11 Device Description max 2000 characters FDA GUDID Description Additional relevant information about the device that is not already captured as a distinct GUDID data attribute Data Entry Notes Enter device description On
124. dical device product data This is referred to as a Unique Device Identifier Database UDID For more information in UDI at a global level and how GS1 standards support it refer to the UDI page on the GS1 website The illustration below provides a basic cross reference between UDI terms and the corresponding GS1 standard UDI GS1 Standards Unique Device Identification Product Identification UDID i GDSN Data Elements linked to the Device Identifier i Attributes mapped to each UDID data element DiI jj GOR Device Identifier DI f Global Trade Item Number Production data is not stored in UDI or GDSN databases PI Al Production Identifier PI if applicable Application Identifiers Al Production Identifier data will vary by Expiration Date Al 17 e g 141120 medical device type and manufacturer i Lot Batch Al 10 e g 1234AB current practice Serial Number Al 21 e g 12345XYZ DI PI UDI Illustration The United States Food and Drug Administration is the first regulator to issue an UDI rule In addition the U S FDA operates a database called Global Unique Device Identifier Database GUDID designed to store medical device product data For more information on the U S FDA UDI and GUDID and how GS1 standards support it refer to the UDI page on the GS1 US website 1 5 Master Data Management and Governance One of the most challenging areas related to implementation of the UDI regulation is the Master Data Managemen
125. e storageHandlingTemperatureMinimum storageHandlingHumidityMinimum ttransportationMinimumTemperature Definition The minimum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value The minimum humidity in percentages that the goods should be stored in The minimum temperature that a trade item can be held below during transport as defined by the manufacturer without affecting product safety or quality Temporary Attributes Attribute Name a storageEnvironmentAtmosphericPressureMinimum b transportationEnvironmentAtmosphericPressMinimum c transportationMaximumHumidityMinimum Definition a The minimum atmospheric pressure in which the item should be stored to remain usable This value is the value below which the trade item should not be subjected b The minimum atmospheric pressure in which the item should be transported to remain usable This value is the value below which the trade item should not be subjected c The minimum humidity in percentages in which the trade items should be transported Data Type Measurement GDSN Required OPTIONAL Population Guidance below The GDSN attributes are pairs of attributes with a minimum and a maximum value This provides a range of applicability for the device for that temperature humidity pressure pair The applicable storage type can be derived from the attribute name Issue 1 Apr 2014 All contents copyright GS1 Page 1
126. e 1 Apr 2014 All contents copyright GS1 Page 151 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition The value to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user For example 16 gauge for a needle or 200 cc for a syringe Carries a UoM from the Recommendation 20 code list Data Type Numeric GDSN Required OPTIONAL Final Deployment Attribute Name clinicalSizeValue Definition The value to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user For example 16 gauge for a needle or 200 cc for a syringe Carries a UoM from the Recommendation 20 code list Data Type Measurement numeric amp UoM qualifier GDSN Required OPTIONAL Population Guidance below This attribute has a temporary attribute AVP in GDSN clinicalSizeValue It will be deployed into the GDSN Schema in 2016 17 into a final solution This GUDID attribute is a measurement attribute specifying the clinical measure of the device This attribute is a numeric value and an associated Unit of Measure UoM qualifier The UoM is a code from the UN Recommendation 20 Code List The Data Pools will convert the UN Rec 20 code to the applicable code for the GUDID if needed For the GUDID the data pools will populate the numeric value in the GUDID attribute Size Value and the UoM qualifier in the GUDID attribute
127. e FDA GUDID Packaging Type Code CYL Cylinder Cylinder A rigid cylindrical container with straight sides and circular ends of equal size Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code DBK Dry Bulk Dry Bulk Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code DRK Double length Rack Double length Rack Issue 1 Apr 2014 All contents copyright GS1 Page 73 of 163 FDA GUDID Attribute Code Value Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Packaging Type Code DRM Description where needed Drum Definition Drum Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code
128. e and Handling Pending UoM UN Recommendation 20 64 Pound per square inch Gauge Psig pound force per square inch gauge is a unit of pressure relative to the surrounding atmosphere At sea level Earth s atmosphere actually exerts a pressure of 14 7 psi Humans do not feel this pressure because internal pressure of liquid in their bodies matches the external pressure If a pressure gauge is calibrated to read zero in space then at sea level on Earth it would read 14 7 psi Thus a reading of 30 psig on Earth on a tire gauge represents an absolute pressure of 44 7 psi Ib in UoM UoM Pending Pending UoM UN Recommendation 20 UoM UN Recommendation 20 58 2N Net kilogram Decibel A unit of mass defining the total number of kilograms after deductions A measurement for sound in air and other gases relative to 20 micropascals uPa 2x10 5 Pa the quietest sound a human can hear Issue 1 Apr 2014 All contents copyright GS1 Page 51 of 163 FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value Description where needed GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition This is roughly the sound of a mosquito flying 3 metres away This is often abbreviated to just dB however the correct abbreviation is dB SPL indicating decibel for Sound Pressure Level
129. e character level of its unit of alphanumeric use Its purpose value If Device is to associate Count 1 cannot the use of a add Unit of Use device to on a DI Number atient Labeler DUNS Business Choose Can edit after 1 1 Numeric 9 from DUNS Number number issued appropriate Grace Period Required by Dun amp DUNS Number Bradstreet D amp B from drop down that matches the Labeler Company name on device label Company Name Company name System Can be edited 1 1 Alphanumeric N A associated with populated through D amp B Required the labeler only DUNS Number entered in the DI Record This name should match the company name on the device label Company Company System Can be edited 1 1 Alphanumeric N A Physical physical address populated through D amp B Required Address associated with only the DUNS Number entered in the DI This address should match the address on the device label Issue 1 Apr 2014 All contents copyright GS1 Page 15 of 163 Brand Name The Proprietary Trad e Brand name of the medical device as used in device labeling or in the catalog This information may 1 be ona label attached to a durable device 2 be ona package of a disposable device or 3 appear in labeling materials of an implantable device The brand name is the name that is typically registered with USPTO and have the and or TM symbol
130. e handled in the GDSN and the GUDID using the following chart __ Information Type Availabe Poputean Value Range of Lowest to Highest Minimum or Low Values Field Lowest Value Maximum or High Values Field Highest Value Less Than a Value Minimum or Low Values Field Leave Null provide no value Maximum or High Values Field Highest Value Greater Than a Value Minimum or Low Values Field Lowest Value Maximum or High Values Field Leave Null provide no value Single or Recommended Value Minimum or Low Values Field Single Same Value populated in both Maximum or High Values Field fods 54 Low Value FDA GUDID Description Indicates the low value for storage and handling requirements Data Entry Notes Must enter a Low Value and or High Value if entering a Storage and Handling Type Edit Rules After Grace Period Can edit add or delete after Grace Period Issue 1 Apr 2014 All contents copyright GS1 Page 156 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Required 0 Not Required Required if Storage and Handling is provided Data Type amp Length Numeric 1 6 digits Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name LOGICAL POPULATION Logical value based on the attribute single or pair chosen to be populated for the device The list of applicable attributes are Current Attributes Attribute Nam
131. e patient For Single Use TRUE Healthcare Trade Item SINGLE_USE Item is not intended to be reused Reusability Labeler DUNS Additional Party DUNS N A Identification Type Labeler DUNS Additional Party DUNS_PLUS_FOUR N A Identification Type MRI Safety Status MR Conditional mRICompatibility MRI_Conditional Indicates that a healthcare trade item is safe to use under specified conditions in a Magnetic Resonance Imaging MRI System MRI Safety Status MR Safe mRICompatibility MRI_Safe Indicates tht the healthcare trade item is safe to use within a Magnetic Issue 1 Apr 2014 All contents copyright GS1 Page 62 of 163 FDA GUDID Attribute Code Value GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition Resonance Imaging MRI system code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID MRI Safety Status MR Unsafe mRICompatibility MRI_Unsafe Indicates that a healthcare trade item is not safe to use in an MRI system MRI Safety Status MR Unsafe mRICompatibility UNSPECIFIED The manufacturer of the Trade Item has not communicated information on the compatibility of this trade item with a Magnetic Resonance Imaging MRI System Over the Counter OTC Over the C
132. e product is free from natural rubber latex S peanuts Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_PROTEI The item is physically marked as natural rubber latex N being free from protein as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_PVC The item is physically marked as natural rubber latex being free from PVC Polyvinyl chloride as approved by the appropriate authority of the target market Device labeled as Not made with FALSE spackageMarksFreeFrom FREE_FROM_ SOYA Free from soya natural rubber latex Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_SUGAR Marks if the product is free from natural rubber latex sugar Device labeled as Not made with FALSE packageMarksFreeFrom REDUCED_LACTOSE Indicates if the amount of lactose is natural rubber latex reduced Device labeled as Not made with FALSE packageMarksFreeFrom REDUCED_PROTEIN The item is physically marked as natural rubber latex containing a low level of protein as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom VERY_LOW_GLUTEN The item is physically marked as as a natural rubber latex very low amount of gluten Very low is frequently determined through regulation for example per EU Regulation EC No 41 2009 of 20 January 2009 this is defined as containing
133. ect is used UoM Size Unit of Measure Pending UoM UN EA Each A unit of count defining the number of Recommendation 20 items regarded as separate units UoM Size Unit of Measure Pending UoM UN FOT Foot The international foot is defined to be Recommendation 20 equal to 0 3048 meters UoM Size Unit of Measure Pending UoM UN H87 Piece A unit of count defining the number of Recommendation 20 pieces piece a single item article or exemplar UoM Size Unit of Measure Pending UoM UN INH Inches An international inch is defined to be Recommendation 20 equal to 25 4 millimeters UoM Size Unit of Measure Pending UoM UN KMT Kilometre A kilometre is one thousand 1000 Issue 1 Apr 2014 All contents copyright GS1 Page 58 of 163 FDA GUDID Attribute Code Value GS1 GDSN Attribute Recommendation 20 Code Value Description where needed GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition metres UoM Size Unit of Measure Pending UoM UN KT Kit A unit of count defining the number of Recommendation 20 kits kit tub barrel or pail UoM Size Unit of Measure Pending UoM UN LF Linear foot A unit of count defining the number of Recommendation 20 feet 12 inch in length of a uniform width object UoM Size Unit of Measure Pending UoM UN LK Link A unit of distance equal to 0 01 chain Recommendation 20 UoM Size Uni
134. ecting it during distribution storage and or exhibition Cases are mostly intended to store and preserve its contents during the product s entir Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in Packaging Type Code CBC Containers of Bulk Cargo Containers of Bulk Cargo Issue 1 Apr 2014 All contents copyright GS1 Page 68 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CBY Carboy Carboy Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CCS Can Case Can Case Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CG Card Card A flat package to which the produ
135. ed After the grace period ends on day 8 this attribute can not be deleted 22 Package Type FDA GUDID Description Text to describe the outer packaging of the product and enables users to understand higher level packaging configurations Data Entry Notes Free text Edit Rules After Grace Period Can add with new package configuration after Grace Period but cannot delete Required 0 1 Not Required Data Type amp Length Alphanumeric 20 Entry List of Values LOV N A New DI Trigger NO Public Private Status Private GS1 GDSN Attribute Name packagingT ypeCode Definition The code identifying the type of package used as a container of the trade item Data Type Text 1 3 characters GDSN Required Optional Population Guidance below The GDSN attribute is a code list and is mapped to the values needed for the GUDID In GDSN the packaging type code is a 3 character code to identify the type of packaging used for the globalTradeltemNumber In this case this value refers to the globalTradeltemNumber which is Issue 1 Apr 2014 All contents copyright GS1 Page 126 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide being used to populate the GUDID Package DI Number The GUDID is asking for a descriptive term and not the code There is a mapping list from which the data pools can populate the appropriate descriptive term to publish to the GUDID Once published a 7 day grace period be
136. ed This uses a measurement consisting of a unit of measure and a value GUDID Code for Storage Type Storage environment temperature storageHandlingTemperatureMinimum UoM storageHandlingTemperatureMaximum UoM Numeric Code List Numeric Code List The minimum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value The maximum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value GUDID Code for Storage Type Storage environment temperature GUDID Code for Storage Type Storage environment temperature All contents copyright GS1 Page 46 of 163 FDA GUDID Data Element Issue 1 Apr 2014 GS1 GDSN Attribute Name storageHandlingTemperatureMinimum UoM transportationEnvironmentAtmospheric PressureMaximum UoM transportationEnvironmentAtmospheric PressureMinimum UoM GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GDSN Data Type Numeric Code List Numeric Code List Numeric Code List GDSN Definition The minimum temperature at which the trade item can be stored This uses a measurement consisting of a unit of measure and a value The maximum atmospheric pressure in which the item should be transported to remain usable This value is the value above which the trade item should not be
137. ed for that specific product Accuracy Is data precise correct and current a Conformity Have formatting rules and standards been applied properly Logic Is data valid or conflicting across product classes Consistency Is data consistent across systems for the same field a Integrity Are there appropriate data linkages between internal systems Duplication Are there unnecessary representations of the same data Issue 1 Apr 2014 All contents copyright GS1 Page 8 of 163 1 8 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide For specific information regarding data quality and validation requirements of the U S Global UDI Database refer to FDA regulation and User Guide 3 Publish and Activate Once the data is created enriched validated and approved it can be published and activated for use Publication can refer to internal users catalogs or the GDSN Source Data Pool for data synchronization with external users In relationship to UDI the data should now be ready for registration in the corresponding UDI database such as the U S FDA GUDID Section two of this document outlines three ways for registering data with the U S FDA s GUDID including how to use a GDSN Data Pool to register the data on behalf of the manufacturer 4 Audit and Evaluate Part of the information lifecycle management includes routine monitoring to ensure the data is fit for purpose This is typical
138. efinition Indication of the food ingredients that the package is marked free from Data Type Code List GDSN Required OPTIONAL Population Guidance below This GDSN attribute is a code list of values representing markings on the packaging The markings signify the device is Free from certain ingredients irritants or allergens This GDSN attribute is only populated to signify what is called out in one of these markings The device might be free from one or more of the ingredients signified by a code value in the code list However the actual code value is only populated here if there is an actual mark on the package calling out the ingredient is not present If a value of FREE_FROM_LATEX is published in the GDSN attribute packageMarksFreeFrom attribute a value of TRUE will be populated in the GUDID Any other code value published in GDSN will populate a value of FALSE for this GUDID attribute Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be edited but only under certain circumstances See Edit Rules After Grace Period for more details 46 Prescription Use Rx FDA GUDID Description Indicates that the device requires a prescription to use Data Entry Notes Select check box if appropriate Webtool Edit Rules After Grace Period Can add or delete after Grace Period Required 0 1 Not Required Data Type
139. ely 30 grams UoM Pending UoM UN OZA Fluid ounce US A fluid ounce US is equal to one Recommendation 20 sixteenth 1 16 of a US pint or 29 5735295625 millilitres UoM Pending UoM UN OZI Fluid ounce UK A fluid ounce UK is equal to one Recommendation 20 thirtieth 1 30 of a UK pint or 28 4130625 millilitres UoM Pending UoM UN P1 Percent A unit of proportion equal to 0 01 Recommendation 20 UoM Pending UoM UN PD Pad A unit of count defining the number of Recommendation 20 pads pad block of paper sheets fastened together at one end UoM Pending UoM UN PR Pair A unit of count defining the number of Recommendation 20 pairs pair item described by two s UoM Pending UoM UN PTD Dry Pint US The United States dry pint is equal Recommendation 20 one eighth of a US dry gallon or one half US dry quarts It is used in the United States but is not as common as the liquid pint UoM Pending UoM UN PTI Pint UK A pint UK is equal to 1 8 Gallon Recommendation 20 UK used primarly as a measure for beer and cider when sold by the glass UoM Pending UoM UN PTL Liquid pint US The US liquid pint is equal one eighth Recommendation 20 of a United States liquid gallon UoM Pending UoM UN QB Page hardcopy A unit of count defining the number of Recommendation 20 hardcopy pages hardcopy page a page rendered as printed or written output on paper film or other permanent medium UoM Pending UoM UN QTD Quart US dry A US dry qu
140. em may be a UoM Pending UoM UN G24 Tablespoon Tablespoon 1 2 fluid ounces 3 Recommendation 20 teaspoons 15 millilitres Issue 1 Apr 2014 All contents copyright GS1 Page 100 of 163 G 1 FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value Description GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition Recommendation 20 yard where needed UoM Pending UoM UN G25 Teaspoon Teaspoon 1 6 fluid ounces or 5 Recommendation 20 millilitres UoM Pending UoM UN GBQ Gigabecquerel A unit of activity equal to 109 Recommendation 20 becquerels UoM Pending UoM UN HEP Histamine Histamine equivalent prick testing for Recommendation 20 Equivalent Prick allergen UoM Pending UoM UN HL Hundred Feet Recommendation 20 UoM Pending UoM UN JR Jar Recommendation 20 UoM Pending UoM UN KE Keg Recommendation 20 UoM Pending UoM UN KEL Kelvin Kelvin a unit of absolute temperature Recommendation 20 equal to 1 273 16 of the absolute temperature of the triple point of water One kelvin degree is equal to one Celsius degree UoM Pending UoM UN KIU Kallikrein Kallikrein Inactivator Unit per Milliliter Recommendation 20 inactivator unit definition An arbitrary unit of a kallikrein inactivator concentration equal to the concentration at which one milliliter of the mixture contains one
141. endation 20 UoM Pending UoM UN D32 Terawatt hour A terawatt hour is 109 kilowat hour Recommendation 20 or 3 6 petajoules UoM Pending UoM UN D63 Book A unit of count defining the number of Recommendation 20 books book set of items bound Issue 1 Apr 2014 All contents copyright GS1 Page 53 of 163 FDA GUDID Attribute Code Value G 1 GS1 GDSN Attribute Code Value Description where needed GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition together or written document of a material whole UoM Pending UoM UN DAY Days A day is one three hundreds and sixty Recommendation 20 fifth 1 365 of a year UoM Pending UoM UN DD Degree Unit of A measurement of plane angle Recommendation 20 Angel representing 1360 of a full rotation one degree is equivalent to 11 180 radians UoM Pending UoM UN DG Decigram A decigram is one tenth 1 10 of a Recommendation 20 gram UoM Pending UoM UN DLT Decilitre A decilitre is one tenth 1 10 of a litre Recommendation 20 UoM Pending UoM UN DMK Square decimetre A square deciimetre is an area of a Recommendation 20 square whose sides are exactly 1 deciimetre in length UoM Pending UoM UN DMQ Cubic decimetre A cubic decimetre is the volume of a Recommendation 20 cube of side length one decimetre 0 1 m UoM Pending UoM UN E34 Gigabyte A unit of in
142. er Database GUDID Implementation Guide GS1 GDSN Attribute Packaging Type Code Code Value TLD Description where needed Intermodal Trailer Container Load Rail Definition Intermodal Trailer Container Load Rail Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code TNK TRC Tank Tierce Tank Tierce Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code TRK TRU Trunk and Chest Truck Trunk and Chest Truck Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in Packaging Type Code TRY Tray Tray A shallow container which may or may not have a cover used for displaying or carrying items
143. er section 515 of the FD amp C Act in order to obtain marketing clearance Issue 1 Apr 2014 All contents copyright GS1 Page 133 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Please note that some Class IIl pre amendment devices may require a Class IIl 510 k See Historical Background2 for additional information Data Type BOOLEAN GDSN Required OPTIONAL Population Guidance belwo This attribute has a temporary attribute AVP in GDSN exemptFromFDAPreMarketAuthorization It will be deployed into the GDSN Schema in 2016 17 into a final solution This Boolean attribute is used to denote if an item is such that is does not require a pre market authorization from the FDA termed an exemption A value of TRUE for this GDSN attribute signifies that the item has been deemed exempt from needing this type of review A value of FALSE or a NULL value will signify that an authorization is required for the item Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 31 FDA Premarket Submission Number FDA GUDID Description Number associated with the regulatory decision regarding the applicant s legal right to market a medical device for the following submission types 510 k PMA PDP
144. erm in the description field at right should be passed to the FDA GUDID Packaging Type Code HRB On Hanger or Rack in Boxes On Hanger or Rack in Boxes Issue 1 Apr 2014 All contents copyright GS1 Page 77 of 163 FDA GUDID Attribute Code Value Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Packaging Type Code Code Value HRK Description where needed Half Standard Rack Definition Half Standard Rack Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code HTB INT Half Standard Tote Bin Intermediate Container Half Standard Tote Bin Intermediate Container Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN util
145. ers schema chosen in addition to Code value managed by FDA EAN UCC classification schema FDA will populate based on the FDA Product Code FDA Listing Type of the identification system that is being used as Goste Lisi an alternative to the Global Trade Item Number additionalTradeltemldentificationType Alternative means to the additionalTradeltemldentificationValue Code List Global Trade Item Number to identify a trade item GMDN Issue 1 Apr 2014 All contents copyright GS1 Page 41 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN Definition GDSN Notes Section 510 k of the Food Drug and Cosmetic Act requires device manufacturers who must register to notify FDA of their intent to market a medical device at least 90 days in advance This is known as Premarket Notification also called PMN or 510 k This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories Specifically medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effective
146. esulting from a force of one pound force applied to an area of one square inch Other abbreviations are used that append a modifier to psi However the US National Institute of Standards and Technology recommends that to avoid confusion any modifiers be instead applied to the quantity being measured rather than the unit of measure 1 For example Pg 100 psi rather than Page 105 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Guidance on populating values This section provides guidance on how to populate each of the GS1 GDSN attributes to meet the requirements of the FDA GUDID attribute list The choice of attributes in this guidance is related to the GUDID to GDSN Mapping provided in section 4 The guidance is ordered according in line with the order as presented from the FDA documentation 1 2 Issuing Agency FDA GUDID Description Organization accredited by FDA to operate a system for the issuance of UDIs Data Entry Notes Choose a value from the drop down list Webtool Edit Rules After Grace Period Cannot edit add or delete after the Grace Period Required 1 1 Required Data Type amp Length Alphanumeric 30 Entry List of Values LOV GS1 HIBCC ICCBBA New DI Trigger YES Public Private Status PUBLIC GS1 GDSN Attribute Name N A LOGICAL POPUALTION Definition N A Data Type N A GDSN Required N A Population Guidance below LOGICAL POPULATION On
147. et by labeler Data Entry Notes Enter an alphanumeric value Issue 1 Apr 2014 All contents copyright GS1 Page 111 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Edit Rules After Grace Period Cannot edit after Grace Period Required 1 1 Required Data Type amp Length Alphanumeric and symbols 40 Entry List of Values LOV N A New DI Trigger YES Public Private Status Public GS1 GDSN Attribute Name Pair of attributes in combination a additionalTradeltemldentificaton type b additionalTradeltemldentificaton value Definition a Type of the identification system that is being used as an alternative to the Global Trade Item Number b Alternative means to the Global Trade Item Number to identify a trade item Data Type a Code List Multiple Occurrence b Text Multiple Occurrence GDSN Required OPTIONAL however if one of the pair is populated the other must be populated Population Guidance below The GUDID is asking for a Model Number for the device This can be accomplished by the population of the code value MODEL NUMBER in the GDSN _ attribute additionalPartyldentification type The actual Model Number can then be populated in the GUDID using the associated additionalPartyldentification value s The code value of MODEL_NUMBER is defined as Definition for GDSN Major Release 3 x in 2016 The additional Trade Item Identification value populated is
148. ever GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Ms2 MSCVAN MSCVAN A commercial leased or Government owned shipping container controlled by the Military Sealift Command Issue 1 Apr 2014 All contents copyright GS1 Page 81 of 163 Packaging Type FDA GUDID Attribute Code Value GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Packaging Type Code Code Value MXD Description where needed Mixed Definition Mixed Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code NOL PA Noil Packet Noil Packet Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to t
149. f date marked on the packaging for example Best Before Date Data Type Code List GDSN Required OPTIONAL Population Guidance below This attribute has a temporary attribute AVP in GDSN isTradeltemManagedByManufactureDate It will be deployed into the GDSN Schema in 2016 into a final solution This GUDID attribute is a Boolean clarifying how the item is controlled It is not for the population of actual manufacturing dates Neither the GUDID nor GDSN are used to provide actual manufacturing dates These should be communicated in transactional documents such as packaging shipping and invoice documents Issue 1 Apr 2014 All contents copyright GS1 Page 143 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide A value populated of TRUE for the temporary attribute or of PRODUCTION_DATE for the attribute tradeltemDateOnPackagingT ypeCode signifies that the item has as one of its controls a manufacture date It also signifies that the manufacture date will be printed on the packaging and in the UDI 42 Serial Number FDA GUDID Description Flag to indicate the device is managed by serial number This number can be found on the device label or accompanying packaging it is assigned by the labeler and should be specific to each device Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Can edit after Grace Period Required 1 1 Require
150. f pre market authorization requirements per 21 CFR 807 28 f Data Entry Notes Enter all applicable Listing Numbers Edit Rules After Grace Period Can add after Grace Period but cannot delete or edit Required 0 Required for all medical devices except for HCT Ps Kits and IVDs BL premarket submission number Data Type amp Length Alphanumeric 7 Entry List of Values LOV N A New DI Trigger NO Public Private Status Private GS1 GDSN Temporary population until final GDSN deployment fDAMedicalDeviceListing Definition Most Owners or operators of places of business also called establishments or facilities that are involved in the production and distribution of medical devices intended for use in the United States U S are required to list the devices that are made at their facility and the activities that are performed on those devices Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments Knowing where devices are made increases the nation s ability to prepare for and respond to public health emergencies Data Type Text GDSN Required Optional Final Deployment Attribute Name Pair of attributes in combination Issue 1 Apr 2014 All contents copyright GS1 Page 138 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide a additionalTradeltemldentificaton type Code of FDA_MEDICAL_DEVICE_LISTIN
151. fication schema Data Type a Code List Multiple Occurrence b Text 1 35 characters Multiple Occurrence GDSN Required OPTIONAL however if one of the pair is populated the other must be populated Population Guidance below This attribute has a temporary attribute AVP in GDSN fDA510KPremarketAuthorization It will be deployed into the GDSN Schema in 2016 17 into a final solution This set of attributes will allow for the population of a Pre Market Authorization number for the device This number will correlate to the scientific and regulatory review information which was created to evaluate the safety and efficacy of the device This set of attributes is required to be provided when the value populated for the GDSN attribute exemptFromFDAPreMarketAuthorization is not TRUE This set of attributes will also be used to populate several other pieces of information FDA Product Code FDA Premarket Submission Number and GMDN For supply chain use this set of attributes can also provide the UNSPSC codes for the device Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be added but can not be edited or deleted 32 Supplement FDA GUDID Description Number assigned by FDA to a supplemental application for approval of a change in a medical device with an approved PMA HDE or PDP Data Entry Notes Enter all valid Supple
152. field at right should be passed to the FDA GUDID Packaging Type Code RCK Rack A non specific term identifying a framework or stand for carrying holding or storing items Commonly on wheels and primarily used in the logistical functions to deliver items such as hanging garments or items on shelves such as dairy products and baker Issue 1 Apr 2014 All contents copyright GS1 Page 85 of 163 FDA GUDID Attribute Code Value Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Packaging Type Code Code Value REL Description where needed Reel Definition Reel A spool on which thread wire film etc is wound Any device on which a material may be wound Usually has flanged ends and is used for shipping or processing purposes Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code
153. figuration For example Package configuration Carton with Package Dl 201 contains 4 boxes of the base package Dl 101 the quantity per package is 4 Package configuration Case with Package DI 301 contains 5 cartons of Package Dl 201 the quantity per package is 5 Package configuration Carton with Package Dl 202 contains 10 boxes of the base package DI 101 the quantity per package is 10 The quantity of a package configuration needs to be greater than 1 Can add with new package configuration after Grace Period but cannot delete GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 0 Required if Package Configuration is entered Numeric 9 N A Issue 1 Apr 2014 All contents copyright GS1 Page 20 of 163 Coniains DI Package The primary DI for the base package or any lower level package configuration contained within a given package configuration For example Package DI 201 and Package Dl 202 contain the base package Case with primary DI 101 Package DI 301 contains lower level package configuration of a Carton with Package DI 201 Choose a value from the drop down Can add with new package configuration after Grace Period but cannot delete GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 0 Required if Package Configuration is entered Alphanumeric
154. formation equal to 109 Recommendation 20 bytes UoM Pending UoM UN E35 Terabyte A unit of information equal to 1012 Recommendation 20 bytes UoM Pending UoM UN E4 Gross kilogram A unit of mass defining the total Recommendation 20 number of kilograms before deductions UoM Pending UoM UN FTK Square foot A square foot is an area of a square Recommendation 20 whose sides are exactly 1 foot in length UoM Pending UoM UN FTQ Cubic foot A cubic foot is the volume of a cube of Recommendation 20 side length one foot 0 3048 m UoM Pending UoM UN G23 Peck A peck is an imperial and U S Recommendation 20 customary unit of dry volume equivalent in each of these systems to 2 gallons 8 dry quarts or 16 dry pints UoM Pending UoM UN GLI Gallon UK The imperial UK gallon was legally Recommendation 20 defined as 4 54609 litres UoM Pending UoM UN GLL Gallon US The U S liquid gallon is legally Recommendation 20 defined as 231 cubic inches and is equal to exactly 3 785411784 litres or about 0 133680555 cubic feet UoM Pending UoM UN GM Gram per square In the metric system the density of all Recommendation 20 metre types of paper paperboard and fabric is expressed in terms of grams per square meter g m This quantity is commonly called grammage both in English and French ISO 536 though many English speaking countries still refer to the weight The term density Issue 1 Apr 2014 All conten
155. ge 96 of 163 FDA GUDID Attribute Code Value Support Contact Phone UoM Use to provide the Contact Phone for GUDID Pending GS1 GDSN Attribute Communications Channel UoM UN Recommendation 20 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Code Value TELEPHONE 23 Description where needed Grams Per Cubic Centimetre Definition N A Grams Per Cubic Centimetre UoM Pending UoM UN Recommendation 20 59 Part per million A unit of proportion equal to 10 6 ppm UoM Pending UoM UN Recommendation 20 64 Pounds per square inch gauge At sea level Earth s atmosphere actually exerts a pressure of 14 7 psi Humans do not feel this pressure because internal pressure of liquid in their bodies matches the external pressure If a pressure gauge is calibrated to read zero in space then at sea level on Earth it would read 14 7 psi Thus a reading of 30 psig on Earth on a tire gauge represents an absolute pressure of 44 7 psi Ib in UoM Pending UoM UN Recommendation 20 2Q Kilo Becquerel kBq is 10 Bq UoM Pending UoM UN Recommendation 20 4N Megabecquerel 106 Bai Bq is defined as the activity of a quantity of radioactive material in which one nucleus decays per second UoM UoM Pending Pending UoM UN Recommendation 20 UoM UN Recommendation 20 A24 Al
156. ge Storage and Handling storageHandlingHumidit Environment GDSN Attributes yMaximum Humidity Storage and Handling Type Storage Storage and Handling storageHandlingHumidit Environment GDSN Attributes yMinimum Humidity Storage and Handling Type Storage Storage and Handling storageHandlingTemper atureMaximum storageHandlingTemper Environment GDSN Attributes atureMinimum Loo CTemperature __ Storage and Handling Type Handling Storage and Handling transportationEnvironme Environment GDSN Attributes ntAtmosphericPressure Atmospheric Maximum Pressure Storage and Handling Type Handling Storage and Handling transportationEnvironme Environment GDSN Attributes ntAtmosphericPressure Atmospheric Minimum Pressure Storage and Handling Type Handling Storage and Handling transportationMaximum Environment GDSN Attributes HumidityMaximum Humidity Storage and Handling Type Handling Storage and Handling transportationMaximum Environment GDSN Attributes HumidityMinimum Humidity Storage and Handling Type Handling Storage and Handling transportationMaximum Environment GDSN Attributes Temperature Temperature Storage and Handling Type Handling Storage and Handling transportationMinimumT Environment GDSN Attributes emperature Temperature Support Contact Email Use to provide the Contact Email for GUDID Communications Channel EMAIL N A Issue 1 Apr 2014 All contents copyright GS1 Pa
157. ght to Medium Blonde b Additional variants necessary to communicate to the industry to help define the product Multiple variants can be established for each GTIN Data Type a Text Language Qualifier 1 to 178 Characters b Text 1 350 characters GDSN Required OPTIONAL Population Guidance below These two attributes will be concatenated together into one value when provided to the GUDID The concatenation of these two descriptions will provide the best description available as some labellers might have used only one of the two fields If only one of the attributes is populated in GDSN only that value will be populated in the GUDID 12 DI Record Publish Date mm dd yyyy FDA GUDID Description Indicates the date the DI Record gets published and is available via Public Search Data Entry Notes Choose date from calendar or manually enter in format mm dd yyyy Drop down is for Webtool only Edit Rules After Grace Period Cannot edit add or delete after Published Required 1 1 Required Data Type amp Length Numeric date format 10 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Issue 1 Apr 2014 All contents copyright GS1 Page 114 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Attribute Name effectiveDate Definition The date on which the information contents of the master data version are valid Valid correct or t
158. gins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be deleted 23 Package Discontinue Date FDA GUDID Description Indicates the date this particular package configuration is discontinued by the Labeler Data Entry Notes Choose date from calendar or manually enter in format mm dd yyyy Edit Rules After Grace Period Can add with new package configuration after Grace Period but cannot delete Required 0 Required if both Package Configuration and Commercial Distribution End Date are entered Data Type amp Length Numeric date format 10 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name discontinuedDate Definition Communicate the date on which the trade item is no longer to be manufactured Allows the reuse of the GTIN after 48 months with the explicit exception of Apparel being 30 months and the implicit exception for specialty products e g steel beams Data Type Date Time CCYY MM DDTHH MM SS GDSN Required Optional Population Guidance below This attribute is populated from the globalTradeltemNumber which is being used to populate the GUDID Package DI Number This date is the date when the Package DI has been discontinued or removed from the marketplace If the Primary DI has reached its lastShipDate then any Package DI attached to the Primary DI will need to have a discontinueDate p
159. h absolute is a unit of pressure pressure relative to a vacuum such as that in space At sea level Earth s atmosphere actually exerts a pressure of 14 7 psi Humans do not feel this pressure because internal pressure of liquid in their bodies matches the external pressure If a pressure gauge is calibrated to read zero in space then at sea level on Earth it would read 14 7 psi Thus a reading of 30 psig on Earth on a tire gauge represents an absolute pressure of 44 7 psi Ib in UoM Storage and Handling Type Unit of Measure Pending UoM UN Recommendation 20 PAL Pascal The pascal symbol Pa is the SI derived unit of pressure stress Young s modulus and tensile strength It is a measure of force per unit area defined as one newton per square metre UoM Storage and Handling Type Unit of Measure Issue 1 Apr 2014 Pending UoM UN Recommendation 20 PS All contents copyright GS1 Pound force per square inch The pound force per square inch symbol psi or Ibf in2 or Ibf in2 is a unit of pressure or of stress based on avoirdupois units It is the pressure Page 104 of 163 Issue 1 Apr 2014 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value All contents copyright GS1 Description where needed P 100 psig Definition r
160. he FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code PAF PAL Pallet 4 Way Pail Pallet 4 Way A pallet that permits entry of handling equipment on each of its four sides Pail Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in Packaging Type Code PAT Pallet 2 way Pallet 2 Way A pallet that permits entry of handling equipment on opposing two of its four sides Issue 1 Apr 2014 All contents copyright GS1 Page 82 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description Definition where needed Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PCK Packed Packed not otherwise specified Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code PCS
161. he FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code GGT Gable Top Gable Top A rectangular shaped code value however non stackable package designed GUDID currently primarily for liquids such as juice or needs a term for the milk code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code GNT Net Net A container of meshwork code value however material made from threads or strips GUDID currently twisted or woven to form a regular needs a term for the pattern with spaces between the code The term in threads that is used for holding the description field carrying trapping or confining at right should be something passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code GPB Pallet Box Pallet Box A three dimensional code value however GUDID currently needs a term for the code The term in container which either has a pallet platform permanently attached at its base or alternatively requires a platform for its handling and storage Issue 1 Apr 2014 All contents copyright GS1 Page 76 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition as due to its
162. he device for that temperature humidity pressure pair The applicable storage type can be derived from the attribute name For the GUDID the GDSN attributes with maximum in their name will map the numeric value into the GUDID attribute High Value The GDSN attributes with minimum in their name will map the numeric value into the GUDID attribute Low Value The following grid maps the GUDID code value for Storage Type to the applicable GDSN Attributes GUDID Storage Type Code GDSN Attributes storageHandlingTemperatureMaximum Storage environment temperature storageHandlingTemperatureMinimum oe storageHandlingHumidityMaximum Storage environment humidity storageHandlingHumidityMinimum storageEnvironmentAtmosphericPressureMaximum Storage environment atmospheric storageEnvironmentAtmosphericPressureMinimum AVP pressure transportationMaximumTemperature Handling environment temperature transportationMinimumTemperature transportationMaximumHumidityMaximum Handling environment humidity transportationMaximumHumidityMinimum AVP transportationEnvironmentAtmosphericPressMaximum kanding environment atmosphere transportationEnvironmentAtmosphericPressMinimum AVP pressure Some devices have a temperature humidity or pressure range High Max and Low Min values Some have a greater than or less than value and others have a single or recommended value Population of all possibilities can b
163. hoose a value from the drop down Webtool Edit Rules After Grace Period Cannot edit after Grace Period Required 1 1 Required Data Type amp Length Boolean Entry List of Values LOV Yes No New DI Trigger YES Public Private Status Public GS1 GDSN Attribute Name initialManufacturerSterilisation LOGICAL POPULATION Logical BOOLEAN value of TRUE from the population of any value in initialManufacturerSterilisation Definition Type s of sterilisation that may have been performed by the manufacturer if a trade item is sterile when it comes from the manufacturer Sterilisation refers to any process that effectively kills or eliminates transmissible agents such as fungi bacteria viruses prions and spore forms etc from a surface equipment foods medications or biological culture medium Some methods of sterilisation are through the application of heat radiation and ethylene Data Type Code List GDSN Required OPTIONAL Issue 1 Apr 2014 All contents copyright GS1 Page 161 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Population Guidance below This GDSN attribute is a code list If a value is published in GDSN it indicates that the device is sold as being sterile Therefore if a value is published in the GDSN attribute initial ManufacturerSterilization then a value of TRUE will be populated in the GUDID If no value is published in GDSN then a value of
164. ice Identifier Database GUDID Implementation Guide Labeler DUNS Number FDA GUDID Description Business number issued by Dun amp Bradstreet D amp B that matches the Labeler Company name on device label Data Entry Notes Choose appropriate DUNS Number from drop down Choose appropriate DUNS Number from drop down Webtool Edit Rules After Grace Period Can edit after Grace Period Required 1 1 Required Data Type amp Length Numeric 9 Entry List of Values LOV from DUNS New DI Trigger NO Public Private Status Private GS1 GDSN Attribute Name Pair of attributes in combination a additionalPartyldentification type b additionalPartyldentification value Definition a Identification of a party by use of a code other than the Global Location Number b A party identifier that is in addition to the GLN Data Type a Code List Multiple Occurrence b Text Multiple Occurrence GDSN Required OPTIONAL however if one of the pair of attributes is populated both attributes must be populated Population Guidance below The GUDID is asking for a DUNS number for the Labeler This value will be for the Company as listed on the label For GDSN the Labeler is equivalent to the Brand Owner Population of this value can be accomplished by populating the code values DUNS or DUNS_PLUS_FOUR in the GDSN attribute Additional Party Identification type tied to the attribute Brand Owner GLN The actual DUNS
165. ifts Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code LNR LOG Liners Log Liners Any material that separates a product within a container from the basic walls of the container Log Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code LSE LUG Loose Lug Loose Lug Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in Packaging Type Code LVN Lift Van Lift Van Issue 1 Apr 2014 All contents copyright GS1 Page 80 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID I
166. ight GS1 Page 32 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 4 GS1 GDSN to FDA GUDID Mapping Population of the FDA GUDID through the use of a GS1 GDSN message and a GDSN Certified Data Pool as a Third Party requires an understanding of the GDSN and its attributes While many of the FDA GUDID attributes can be mapped one to one with a GS1 GDSN equivalent there are others that do not map and are logically populated or map via more than one GDSN attribute The first table below provides a mapping between the FDA GUDID attribute list and the corresponding GS1 GDSN Attribute s The attributes listed in the table use the name assigned in the GDSN standards Each user of this document should consult with their GDSN Certified Data Pool for the exact naming convention and message formatting applicable to the contract between the user and the Data Pool The second table below provides a mapping between the FDA GUDID code values and the corresponding GS1 GDSN code values The values listed in the table use the name assigned in the GDSN standards Each user of this document should consult with their GDSN Certified Data Pool for the exact naming convention and message formatting applicable to the contract between the user and the Data Pool FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type Device Information Device Identifier DI Information Numeric 14 globalTradel
167. ill populated for the GUDID attribute It also signifies that the serial number will be printed on the packaging and in the UDI Any other code value published in GDSN will populate a value of FALSE for the GUDID attribute Issue 1 Apr 2014 All contents copyright GS1 Page 144 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 43 By Expiration Date FDA GUDID Description Flag to indicate the device is managed by expiration date The date by which the label of a device states that the device must or should be used Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Can edit after Grace Period Required 1 1 Required Data Type amp Length Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public GS1 GDSN Current GDSN Attribute packagingMarkedExpirationDateType Definition Indicates the type of expiration date marked on the packaging for example Best Before Date Data Type Code List GDSN Required OPTIONAL Final Deployment Attribute Name tradeltemDateOnPackagingTypeCode coming in Major Release in 2016 Definition Indicates the type of date marked on the packaging for example Best Before Date Data Type Code List GDSN Required OPTIONAL Population Guidance below This attribute has a current attribute in GDSN packagingMarkedExpirationDateType It will be changed in the GDSN Major Rele
168. in 2012 during the FDA s user acceptance testing Web based tool iiid pa EN Global UDI e Database BulkHL7SPL QQE GDSN A me Illustration 2 The GDSN is an Internet based interconnected network of interoperable data pools and a Global Registry the GS1 Global Registry that enables companies around the world to exchange accurate standardised and synchronised supply chain data with their trading partners The Global Data Synchronisation Network GDSN enables manufacturers distributors and providers to share accurate product information electronically In addition to receiving the initial product data the customer can receive product update notifications automatically from the supplier The GDSN is an attractive option for manufacturers who also need to provide product master data to providers GPOs and distributors since it allows them to provide the right data to the right party with a single connection as illustrated below Issue 1 Apr 2014 All contents copyright GS1 Page 11 of 163 3 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide i MANUFACTURER v US UDID soervesccseesesseesessee sD HOSPITAL PROVIDER GPO i MANUFACTURER EU UDID Tae Ws i sossossocsoscocsosoosoe gt MANUFACTURER v i MANUFACTURER JAPAN UDID Illustration 3 Regulators are working together via the
169. inical user For example 16 gauge for a needle or 200 cc for a syringe Carries a UoM from the Recommendation 20 code list AVP clinicalSizeValue and clinicalSizeValueUoM clinicalSizeText Text 1 to 200 characters When the clinicalSizeType is coded as other this is the text used to denote the dimensional size which is clinically relevant for the use of the trade item by the clinical user AVP clinicalSizeText Storage and Handling storageEnvironmentAtmosphericPressu reMaximum UoM Numeric Code List The maximum atmospheric pressure in which the item should be stored to remain usable This value is the value above which the trade item should not be subjected AVP storageEnvironmentAtmosphericPressur eMaximum storageEnvironmentAtmosphericPressu reMinimum UoM Numeric Code List The minimum atmospheric pressure in which the item should be stored to remain usable This value is the value below which the trade item should not be subjected AVP storageEnvironmentAtmosphericPressur eMinimum Issue 1 Apr 2014 All contents copyright GS1 Page 45 of 163 el DY 1 0 B DEDEGE SEA Issue 1 Apr 2014 GS1 GDSN Attribute Name storageEnvironmentAtmosphericPressu reMaximum UoM GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GDSN Data Type Numeric Code List GDSN Definition The maximum at
170. ition Platform Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code PLN PLT Pipeline Pallet Pipeline Pallet A platform used to hold or transport unit loads Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code PO POV Pouch Private Vehicle Pouch A preformed flexible container generally enclosed with a gusset seal at the bottom of the pack can be shaped arranged to allow the pack to stand on shelf Private Vehicle Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in Packaging Type Code PRK Pipe Rack Pipe Rack Issue 1 Apr 2014 All contents copyright GS1 Page 84 of 163 FDA GUD
171. izes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code JAR JG Jar Jug Jar A rigid container made of glass stone earthenware plastic or other appropriate material with a large opening which is used to store products e g jams cosmetics Jug A container normally cylindrical with a handle and or a lid or spout for holding and pouring liquids Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in Packaging Type Code KEG Keg Keg Issue 1 Apr 2014 All contents copyright GS1 Page 78 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code KIT Kit Kit Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GU
172. l SizeType Needle Gauge SizeType Second Greatest Clinical SizeType Second Greatest Diameter Diameter SizeType Third Greatest Clinical SizeType Third Greatest Diameter Diameter SizeType Total Volume Clinical SizeType Total Volume SizeType Width Clinical SizeType Width Sterilization Method Moist Heat or Steam Initial Manufacture AUTOCLAVE Autoclave Steam is a method of Sterilization Initial Sterilization Prior to Use sterilisation that utilizes pressure and heat to achieve a sterile environment Sterilization Method Radiation Initial Manufacture BETA_RADIATION Beta particles are able to penetrate Sterilization living matter to a certain extent Initial Sterilization Prior to radiation intensity from a small Use source of radioactive material decreases as one over the distance squared and can change the structure of struck molecules Sterilization Method Ethylene Oxide Initial Manufacture EtO_ETHYLENE_OXID A gas that is commonly used to Issue 1 Apr 2014 Sterilization Initial Sterilization Prior to Use E All contents copyright GS1 sterilize objects sensitive to temperatures greater than 60 C such as plastics optics and electrics Ethylene oxide treatment is generally Page 94 of 163 Sterilization Method FDA GUDID Attribute Code Value Radiation Sterilization Method Dry Heat Sterilization Method High Intensity Light or Pulse Light Sterilization Metho
173. lent in each of these systems to 4 pecks or 8 gallons It is used for volumes of dry commodities not liquids most often in agriculture UoM Pending UoM UN C26 Millisecond A millisecond from milli and second Recommendation 20 abbreviation ms is a thousandth 1 1000 of a second UoM Pending UoM UN CG Card A unit of count defining the number of Recommendation 20 units of card card thick stiff paper or cardboard UoM Pending UoM UN CGM Centigram A centigram is one hundredth 1 100 Recommendation 20 of a gram UoM Pending UoM UN CLT Centimetre A centimetre is equal to one Recommendation 20 hundredth of a metre UoM Pending UoM UN CMK Square centimetre A square centimetre is an area of a Recommendation 20 square whose sides are exactly 1 centimetre in length UoM Pending UoM UN CMQ Cubic centimetre A cubic centimetre is the volume of a Recommendation 20 cube of side length one centimetre 0 01 m equal to a millilitre UoM Pending UoM UN CWA Hundred pound A unit of weight in the U S Customary Recommendation 20 cwt hundred System equal to 100 pounds 45 36 weight US kilograms also called cental UoM Pending UoM UN CWI Hundred weight A unit of weight in the British Imperial Recommendation 20 UK System equal to 112 pounds 50 80 kilograms also called quintal UoM Pending UoM UN D29 Terahertz A unit of frenquecy equal to 1012 Recommendation 20 Hertz UoM Pending UoM UN D30 Terajoule A terajoule is 102 joules Recomm
174. low This attribute provides a value for this attribute when the GDSN attribute clinicalSizeType is required to be populated when a value of OTHER or DEVICE_SIZE_TEXT SPECIFY is published in the GDSN attribute clinicalSizeType This is free text field and should only be used if the clinical size can not be specified using specific values in the Clinical Size Type Code List This attribute is part of a repeatable class of clinical attributes for the device containing the Size Type Size Value and Size Unit of Measure for the device s clinical size Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be added but can not be edited or deleted Storage Type FDA GUDID Description Indicates storage and handling requirements that are required for the device including temperature humidity and atmospheric pressure Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Can edit add or delete after Grace Period Required 0 Not Required Required if Storage and Handling is provided Data Type amp Length Code List Entry List of Values LOV CV for Storage Conditions Storage environment temperature Storage environment humidity Storage environment atmospheric pressure Handling environment temperature Handling environment humidity Handling environment atmospheric pressure New
175. ly or otherwise combined or mixed and produced as a single entity packaged together as a single package or packaged separately for the intended use together as defined under 21 CFR 3 2 e At least one of the products in the combination product must be a device in this case Check box if DI record is for the combination product itself Do not check if the product is a constituent part of a combination product Cannot add or delete after Grace Period 0 1 Not Required Boolean N A Issue 1 Apr 2014 All contents copyright GS1 Page 23 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Premarket the three letter Product Code Product Code Device Exempt Device is exempt Check box if Cannot add or 0 1 Not NO N A from Premarket from FDA appropriate delete after Required Submission Premarket Grace Period Required if regulations or a device is exempt preamendment from premarket device submission FDA Premarket Number Enter all valid Can add after 1 Required Alphanumeric N A Submission associated with FDA Premarket Grace Period Not required if 8 Number the regulatory Submission but cannot Device Exempt decision Numbers delete or edit from Premarket regarding the Submission is applicant s legal selected right to market a Not required for medical device Kits for the
176. ly an ongoing process which is part of a continuous data quality management and improvement process It can be in the form of an actual audit event but generally it is part of the user feedback process as a result of application of the information Ideally the Audit is performed against a set of Metrics or Key performance Indicators Error investigation should include a route cause analysis to determine the cause of the problem and steps to prevent it from re occurring Some organizations include a scorecard to report performance and track improvements over time 5 Update and Maintain The information lifecycle management process should include a step to update information as relevant changes occur in any part of the master data This applies to information about the product as well as well as the organization This step should include notification of the change to the data owner for approval 6 Inactivate and Archive As information is obsoleted and purged it should be removed from active use This may include a flag to indicate that a particular data element is inactive and is no longer used but it is not removed from the listing This is a very relevant step in UDI regulation which requires data which has been made inactive to be permanently stored in a UDI database In general master data management the data element can be archived from the internal active database The determination of which action applies usually depends on particular use
177. ly the and symbols will be supported for the production release Edit Rules After Grace Period Can edit add or delete after Grace Period Required 0 1 Not Required Data Type amp Length Alphanumeric and symbols 2000 Entry List of Values LOV N A Issue 1 Apr 2014 All contents copyright GS1 Page 113 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name Pair of attributes in combination a Trade Item Description b Additional Trade Item Description text Definition An understandable and useable description of a trade item using brand and other descriptors This attribute is filled with as little abbreviation as possible while keeping to a reasonable length Free form text field this data element is repeatable for each language used and must be associated with a valid ISO language code Field length is 178 characters This should be a meaningful description of the trade item with full spelling to facilitate message processing Retailers can use this description as the base to fully understand the brand flavour scent etc of the specific GTIN in order to accurately create a product description as needed for their internal systems Examples 1 GS1 Brand Base Invisible Solid Deodorant AP Stick Spring Breeze 2 GS1 Brand Laundry Detergent Liquid Compact Regular Instant Stain 1 3 GS1 Brand Hair Colour Liquid Li
178. m regarding how it can be sold to the consumer for example Prescription Required Data Type Code List GDSN Required OPTIONAL Population Guidance below This GDSN attribute is a code list of values signifying how the item is presented for sale to a consumer If a value of OTC is published in the GDSN attribute ConsumerSalesCondition attribute a value of TRUE will be populate in the GUDID Any other code value published in GDSN will populate a value of FALSE for this GUDID attribute Issue 1 Apr 2014 All contents copyright GS1 Page 148 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 48 Is the device labeled for MRI Safety FDA GUDID Description Indicates that sufficient testing has been conducted to characterize the behavior of the device in the MR environment See ASTM F2503 13 Data Entry Notes Check box if appropriate Webtool Edit Rules After Grace Period Can add check to checkbox after Grace Period but cannot delete a check from the checkbox Required 0 1 Not Required Data Type amp Length Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name N A LOGICAL POPUALTION Definition N A Data Type N A GDSN Required N A Population Guidance below LOGICAL POPULATION On the outbound GUDID Message by the Data Pool Will use the value TRUE when any code value other than UNSPEC
179. mendation 20 number of complete cycles per second it is the basic unit of frequency in the International System of Units SI UoM Pending UoM UN HUR Hour An hour is a unit of measurement of Recommendation 20 time of the duration of 60 minutes or 3600 seconds It is 1 24 of a median Earth day UoM Pending UoM UN INK Square inch A square inch is an area of a square Recommendation 20 whose sides are exactly 1 inch in length UoM Pending UoM UN INQ Cubic inch A cubic inch is the volume of a cube Recommendation 20 of side length one inch 0 254 m UoM Pending UoM UN JOU Joule A joule is the energy exerted by a Recommendation 20 force of one newton acting to move an object through a distance of one metre UoM Pending UoM UN K6 Kilolitre A kilolitre is one thousand 1000 Recommendation 20 litres UoM Pending UoM UN KGM Kilogram A unit of mass equal to one thousand Recommendation 20 grams UoM Pending UoM UN KHZ Kilohertz A unit of frenquecy equal to 103 Hertz Recommendation 20 UoM Pending UoM UN KJO Kilojoule A kilojoule is 1000 joules Recommendation 20 Issue 1 Apr 2014 All contents copyright GS1 Page 55 of 163 FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value Description where needed GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition UoM Pending UoM UN KWH Kilowa
180. ment Numbers Do not enter any alpha characters Edit Rules After Grace Period Can add after Grace Period but cannot delete or edit Required 0 1 Not Required unless Device contains Supplement Not required if Device Exempt from Premarket Submission is selected Not required for Kits Data Type amp Length Numeric 4 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment fDASupplementNumber Issue 1 Apr 2014 All contents copyright GS1 Page 135 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition Number associated with the regulatory decision regarding the applicant s legal right to market a medical device PMA Supplement After FDA has approved a PMA an applicant must submit a PMA supplement for review and approval by FDA before making any change affecting the safety or effectiveness of the device unless FDA has advised that an alternate type of submission is permitted for a particular change All changes must meet the requirements of the Quality System regulation Good Manufacturing Practices under 21 CFR Part 820 including the design control requirement under 820 30 Changes for which an applicant must submit a PMA supplement include but are not limited to the following types of changes if they affect the safety or effectiveness of the device new indication for use of the device labeling
181. ment Temperature Special that are required Handling is Storage Conditions Storage Environment for the device provided Atmospheric Pressure Storage including Environment Humidity Storage temperature Environment Temperature humidity and atmospheric pressure Low Value Indicates the low Must enter a Low Can edit add or 0 ALow Value Numeric 6 N A value for storage Value and or delete after and or a High and handling High Value if Grace Period Value is required requirements entering a if Storage and Storage and Handling is Handling Type provided High Value Indicates the Must enter a Low Can edit add or 0 A Low Value Numeric 6 N A high value for Value and or delete after and or a High storage and High Value if Grace Period Value is required handling entering a if Storage and requirements Storage and Handling is Handling Type provided Unit of Measure The unit of Choose a value Can edit add or 0 N A Degrees Celsius Degrees Fahrenheit measure from the drop delete after Required if Degrees Kelvin associated with the down Grace Period Storage and Kilo Pascal Percent Relative Humidity storage and Handling is handling provided conditions The unit of measure must conform to UCUM standards Issue 1 Apr 2014 All contents copyright GS1 Page 31 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 0 Not Required
182. ments are locked and can no longer be edited Unit of Use DI Number FDA GUDID Description An identifier assigned to an individual medical device when a UDI is not labelled on the individual device at the level of its unit of use Its purpose is to associate the use of a device to on a patient Data Entry Notes GS1 14 digit numeric value HIBCC 6 23 character alphanumeric value ICCBBA 10 or 16 character alphanumeric value If Device Count 1 cannot add Unit of Use DI Number Edit Rules After Grace Period Can edit after Grace Period if Device Count gt 1 Required 0 Required if device count is greater than one Data Type amp Length Numeric or Alphanumeric 6 23 characters Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1GDSN Attribute Name FDA Unit Of Use GTIN Definition GTIN of a unit of use as defined by the FDA This is a lower level unit which is contained in the Trade Item Data Type GTIN GDSN Required N A Population Guidance below If the Device Count is greater than 1 gt 1 the unit of use DI is required for population in the GUDID This attribute is a temporary attribute AVP in GDSN It will be deployed into the GDSN Schema in 2016 17 into a final solution This final solution will be part of the GDSN solution for Level below Each LBE Issue 1 Apr 2014 All contents copyright GS1 Page 108 of 163 5 6 GDSN for the FDA Global Unique Dev
183. mospheric pressure in which the item should be stored to remain usable This value is the value above which the trade item should not be subjected GDSN Notes AVP storageEnvironmentAtmosphericPressur eMaximum storageEnvironmentAtmosphericPressu reMinimum UoM storageHandlingHumidityMaximum UoM Numeric Code List Numeric Code List The minimum atmospheric pressure in which the item should be stored to remain usable This value is the value below which the trade item should not be subjected The maximum humidity in percentages that the goods should be stored in AVP storageEnvironmentAtmosphericPressur eMinimum GUDID Code for Storage Type Storage environment humidity storageHandlingHumidityMinimum UoM Numeric Code List The minimum humidity in percentages that the goods should be stored in GUDID Code for Storage Type Storage environment humidity storageHandlingHumidityMaximum UoM Numeric Code List The maximum humidity in percentages that the goods should be stored in GUDID Code for Storage Type Storage environment humidity storageHandlingHumidityMinimum UoM Numeric Code List The minimum humidity in percentages that the goods should be stored in GUDID Code for Storage Type Storage environment humidity storageHandlingTemperatureMaximum UoM Numeric Code List The maximum temperature at which the trade item can be stor
184. mplementation Guide GS1 GDSN Attribute Code Value Description where needed Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code MIX Mixed Container Types Mixed Container Types More than one type of container is included in a shipment shipment could consist of 3 pieces that include 1 box 1 crate and 1 basket Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code ML2 MILVAN MILVAN A military owned demountable container that conforms to US and international standards and operates in a centrally controlled fleet for movement of military cargo Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code MPE Multipack Multipack Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code MRP Multi Roll Pack Multi Roll Pack Packaging Type GDSN utilizes the code value how
185. nce of the GDSN attribute communicationChannelCode is populated with the value of EMAIL the corresponding communicationNumber will map to this GUDID attribute This group attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Support Contact Phone and Support Contact Email 27 Human Cell Tissue or Cellular or Tissue Based Product HCT P FDA GUDID Description Indicates that the product contains or consists of human cells or tissues that are intended for implantation transplantation infusion or transfer into a human recipient as defined under 21 CFR 1271 3 Data Entry Notes Check box if appropriate Webtool Edit Rules After Grace Period Can add or delete after Grace Period Required 0 1 Not Required Data Type amp Length Boolean Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name doesTradeltemContainHumanTissue Definition The trade item has as a component or ingredient human tissue The amount of tissue is not limited to a certain amount any amount will cause a flag of TRUE Data Type Boolean Issue 1 Apr 2014 All contents copyright GS1 Page 130 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GDSN Required OPTIONAL Population Guidance below This Boolean attribute should be populated with a v
186. ndation 20 for some specific commodities including 31 gal for beer 40 gal for whiskey or kerosene and 42 gal for petroleum The general standard for liquids is 31 5 gal or half a hogshead the general standard for dry contents is 7 056 Cubic Inches UoM Pending UoM UN BP Hundred board foot A unit of volume equal to one hundred Recommendation 20 board foot UoM Pending UoM UN BTU British thermal unit The British thermal unit BTU or Btu Recommendation 20 is a traditional unit of energy It is Issue 1 Apr 2014 All contents copyright GS1 Page 52 of 163 FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value Description where needed GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition approximately the amount of energy needed to heat one pound of water one degree Fahrenheit One Btu is equal to about 1 06 kilojoules It is used in the power steam generation heating and air conditioning industries UoM Pending UoM UN BUA Bushel US A bushel is an imperial and U S Recommendation 20 customary unit of dry volume equivalent in each of these systems to 4 pecks or 8 gallons It is used for volumes of dry commodities not liquids most often in agriculture UoM Pending UoM UN BUI Bushel UK A bushel is an imperial and U S Recommendation 20 customary unit of dry volume equiva
187. ness could be affected Such change or modification could relate to the design material chemical composition energy source manufacturing process or intended use Category code based on alternate classification Code value managed by GMDN Only additionalClassificationCode Text 1 15 characters schema chosen in addition to the GMDN Code is provided to the EAN UCC classification GUDID Use code 35 schema additionalClassificationAgency Code List Device Characteristics Issue ae Apr 2014 All contents copyright GS1 Page 42 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN Definition GDSN Notes Determines if the product is intended for single or multiple uses including the number of validated cycles and the number of times a product can be used according to the manufacturer specifications It is suggested that medical providers consult the device manufacturer s Instruction For Use IFU for full reusability instructions manufacturerDeclaredReusabilityType Code List Production Identifier s on Label Indication whether the base trade item is batch or lot number requested by law not batch or lot number requested by law but batch or lot number allocated or not batch or lot number allocated A batch or lot number is a manufacturer assigned code used to
188. nformation is being provided For end user or consumer support the code value should be CONSUMER_SUPPORT For the item s regulatory contact information the code value should be LICENSEE_REGISTRAR The GDSN attributes communicationChannelCode and communicationNumber can repeat as a pair of attributes for a single contactType There can be more than one contactType populated for a single Trade item For the GUDID the contactType of CONSUMER_SUPPORT will signify the information to be provided to the GUDID via GDSN Where an instance of the GDSN attribute communicationChannelCode is populated with the value of TELEPHONE the corresponding communicationNumber will map to the GUDID attribute Support Contact Phone This group attributes will be used to provide several sets of information and as such will be repeated as a group GUDID attributes using this group of attributes are Support Contact Phone and Support Contact Email 26 Support Contact Email FDA GUDID Description Email for the support contact Data Entry Notes Enter alphanumeric email address in format Edit Rules After Grace Period Can edit add or delete after Grace Period Required 1 Required if support contact information is entered Data Type amp Length Alphanumeric 100 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name Pair of attributes in combination a contactType b communi
189. nique Device Identifier Database GUDID Implementation Guide Definition of 20 oz yd2 The term density here is used somewhat incorrectly as density is mass by volume More precisely it is a measure of the area density areal density or surface density UoM Pending UoM UN PE Pounds Equivalent Recommendation 20 UoM Pending UoM UN PFU Plaque Forming Plaque Forming unit s Recommendation 20 unit s UoM Pending UoM UN PK Package Recommendation 20 UoM Pending UoM UN PRS Potential Renal Refers to all solutes of endogenous or Recommendation 20 Solute Load dietary origin that require excretion by the kidneys Potential renal solute load PRSL refers to solutes of dietary origin that would need to be excreted in the urine if none were diverted into synthesis of new tissue and none were lost through nonrenal routes This is very important to be able to transmit for infant formulas UoM Pending UoM UN PTN Portion Recommendation 20 UoM Pending UoM UN RL Roll Recommendation 20 UoM Pending UoM UN SH Sheet Recommendation 20 UoM Pending UoM UN SQE SQ E Number of allergens based on the Recommendation 20 SQ E unit UoM Pending UoM UN TE Tote Recommendation 20 UoM Pending UoM UN TK Tank Recommendation 20 UoM Pending UoM UN TM Thousand Feet Recommendation 20 UoM Pending UoM UN TY Tray Recommendation 20 UoM Pending UoM UN UY Fifty Square Feet Recommendation 20 UoM Pending UoM
190. ntly needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code VP VPK Vacuum Packed Van Pack Vacuum Packed Packaging in containers either rigid or flexible from which substantially all gases have been removed prior to final sealing of the container Van Pack Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in Packaging Type Code WHE On Own Wheel On Own Wheel Issue 1 Apr 2014 All contents copyright GS1 Page 92 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code WLC Wheeled Carrier Wheeled Carrier Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in
191. o the FDA GUDID Packaging Type Code UNT Unit Unit Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code UVQ Wrapped in Plastic Wrapped in Plastic Issue 1 Apr 2014 All contents copyright GS1 Page 91 of 163 FDA GUDID Attribute Code Value Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Packaging Type Code Code Value VEH Description where needed Vehicles Definition Vehicles Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code VIL VOC Vial Vehicle in Operating Condition Vial Vehicle in Operating Condition Packaging Type Packaging Type GDSN utilizes the code value however GUDID curre
192. ocument as provided by the FDA GUDID Guidance documents While every effort is made to keep this document up to date the official list of attributes and particulars is the responsibility and jurisdiction of the FDA A website link to the official list is provided in the reference section of this document Users of this document are encouraged to review and become familiar with the official list of attributes and particulars as listed on the FDA s websites The table uses the headers as defined below Header Definition Data Element The name of the element being requested Description Text defining the element Data Entry Notes How the is entry to be accomplished The primary focus of the guidance is primarily written with a web interface user in mind For a machine to machine user the notes will have different meaning and be described in the guidance later in this document Edit Rules After Grace Once published on the FDA GUDID public facing website for the first time the Period user will have a 7 day grace period within which changes can be made This field states what editing can be accomplished after the grace period expires Required Is this data element required to be populated by the FDA 0 in the first position signifies not required 1 in the first position signifies required after 2 periods signifies multiple occurrences repeatability a nd a number after 2 periods signifies single occurrence non repeatability Da
193. od ends on day 8 this attribute can be added but can not be edited or deleted Issue 1 Apr 2014 All contents copyright GS1 Page 136 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 33 Product Code FDA GUDID Description Classification for pre market devices issued by the FDA three letter code Data Entry Notes Enter all applicable Product Codes Edit Rules After Grace Period Can edit add or delete after Grace Period Required 0 Required for all medical devices except for Kits or IVDs BL premarket submission number Data Type amp Length Alpha 3 Entry List of Values LOV FDA Product Code list New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name Pair of attributes in combination a additionalClassificationAgencyName b additionalClassificationCategoryCode Definition a Text name of the additional external classification agency whose schema is being provided in addition to the Global EAN UCC schema Required if additional classification schema fields are populated b Category code based on alternate classification schema chosen in addition to EAN UCC classification schema Data Type a Code List Multiple Occurrence b Text 1 35 characters Multiple Occurrence GDSN Required OPTIONAL however if one of the pair is populated the other must be populated Population Guidance below This repeatable set of attributes will allow
194. of an implantable device The brand name is the name that is typically registered with USPTO and have the and or TM symbol Data Entry Notes Enter the name of the device Only the and symbols will be supported for the production release Edit Rules After Grace Period Cannot edit after Grace Period Required 1 1 Required Data Type amp Length Alphanumeric and symbols 80 Entry List of Values LOV N A New DI Trigger YES Public Private Status Public GS1 GDSN Attribute Name brandName Definition The recognisable name used by a brand owner to uniquely identify a line of trade item or services This is recognizable by the consumer Data Type Text 1 35 characters GDSN Required MANDATORY Population Guidance below This should be the most recognizable brand on the package trade item If there is no brand on the package trade item this should be the brand name under which the item is sold Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be changed Many of the data elements are locked and can no longer be edited Version or Model Number FDA GUDID Description The version or model number found on the device label or accompanying packaging used to identify a category or design of a device The version or model means all devices that have specifications performance size and composition within limits s
195. opathic potency of a substance where each attenuation step represents one part source material combined with 49 999 parts dilution medium commonly denoted as LM1 LM2 LM3 etc A count of a dry crud medical substance Mother tincture when used for homeopathic preparations are liquid preparations obtained by the solvent action of a suitable vehicle upon raw materials The raw materials medical substance are usually in the fresh form but may be dried Mother tinctures for homeopathic preparations may also be obtained from plant juices with or without the addition of a vehicle UoM Pending UoM UN X_NGM Recommendation 20 Nanogram A nano gram is 10 9 gram ora billionth of a gram UoM Pending UoM UN X_PPC Recommendation 20 Pixel per centimetre A unit of count defining the number of pixels per linear centimetre as a measurement of the resolution of devices in various contexts typically computer displays image scanners or digital camera image sensors UoM Pending UoM UN X_PPI Recommendation 20 Pixel per inch A unit of count defining the number of pixels per linear inch PPI asa measurement of the resolution of devices in various contexts typically computer displays image scanners or digital camera image sensors Issue 1 Apr 2014 All contents copyright GS1 Page 103 of 163 FDA GUDID Attribute Code Value UoM UoM Size Unit of Me
196. opulated This ensures that a Package is not active and its contents are not Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute cannot be deleted 24 Package Status FDA GUDID Description Indicates whether the package configuration is available or discontinued Data Entry Notes System populated Issue 1 Apr 2014 All contents copyright GS1 Page 127 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Edit Rules After Grace Period N A Required 0 Required if Published Data Type amp Length Alphanumeric Entry List of Values LOV In Commercial Distribution Not in Commercial Distribution New DI Trigger NO Public Private Status Public GS1GDSN Derived by the FDA GUDID based on effectiveDate and lastShipDate Definition N A Data Type N A GDSN Required N A Population Guidance below If the current date is equal to or greater than the GUDID Publication Date effectiveDate in GDSN of the Primary DI then the Package Status will be set to In Commercial Distribution automatically by the FDA If the current date is equal to or greater than the GUDID Package Discontinue Date lastShipDate for the package level GTIN in GDSN then the Package Status will be set to Not in Commercial Distribution automatically by the FDA Note if the Commercial Distribution Status of the
197. ounter Consumer Sales OTC Over the Counter products that may OTC Conditions be sold without a prescription These products are generally available without restrictions Packaging Type GDSN utilizes the Packaging Type Code AAA Pallet Returnable Pallet Returnable code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code AAB Splash Blend Splash Blend Splash blending is the code value however mixing of two gasoline products of GUDID currently different octane levels in a tank on needs a term for the the delivery vehicle to produce a third code The term in blended grade of motor fuel for resale the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code AE Aerosol Aerosol A gas tight pressure code value however resistant container with a valve and GUDID currently propellant When the valve is needs a term for the opened propellant forces the product code The term in from the container in a fine or coarse the description field spray pattern or stream e g a at right should be spray can dispensing paint furniture passed to the FDA polish GUDID Packaging Type GDSN utilizes the Packaging Type Code AMM Ammo Pack Ammo Pack Issue 1 Apr 2014 All contents copyright GS1 Page 63 of 163 FDA GUDID Attribute Code Value GDS
198. ovided for the GDSN attribute will populate a value of FALSE for the GUDID attribute Combination Issue 1 Apr 2014 All contents copyright GS1 Page 132 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide This attribute will be used to provide several sets of information and as such may be repeated GUDID attributes using this group of attributes are Kit and Combination Product Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 30 Device Exempt from Premarket Authorization FDA GUDID Description Device is exempt from FDA Premarket regulations or a pre amendment device Data Entry Notes Check box if appropriate Edit Rules After Grace Period Cannot add or delete after Grace Period Required 0 1 Not Required Required if device is exempt from premarket submission Data Type amp Length Boolean Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment exemptFromFDAPreMarketAuthorization Definition Device is exempt from FDA Premarket regulations Premarket approval PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class Ill medical devices Class Ill device
199. ovider prior to initial use of the healthcare trade item Sterilisation refers to any process that effectively kills or eliminates transmissible agents Such as fungi bacteria viruses prions and spore forms etc from a surface equipment foods medications or biological culture medium Some methods of sterilisation are through the application of heat radiation and ethylene Data Type Code List GDSN Required OPTIONAL Population Guidance below This GDSN attribute is a code list of the type s of sterilization which can be performed on a device by the Provider prior to use When this attribute is published a value of TRUE will be populated for the GUDID attribute Requires Sterilization Prior to Use Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be edited but only under certain circumstances See Edit Rules After Grace Period for more details 7 References For more information on UDI at a global level refer to http www gs1 org healthcare udi For more information on the IMDREF refer to hito www imdrf org For more information on the U S FDA UDI refer to http www gs 1us org industries healthcare gs 1 healthcare us fda udi For more information on the GDSN refer to Attp Awww gs1 org gdsn For more information on GS1 Healthcare refer to http www gs1 org healthcare For country support contact your local GS1 Member
200. own values are MR Safe MR Conditional and MR Unsafe Please see the ASTM F2503 13 standard for more information on these three values down if selected check box for Has the device been evaluated for MRI Safety after Grace Period only if the field Has the device been evaluated for MRI Safety was previously unchecked Cannot edit after Grace Period if Has the device been evaluated for MRI Safety was previously checked box for Is the device labeled for MRI Safety Issue 1 Apr 2014 All contents copyright GS1 Page 29 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Clinically Relevant Size Size Type Dimension type Choose a value Can add after 0 Not Required N A Circumference Depth Device Size Text for the clinically from the drop Grace Period Required if Size specify French Catheter Gauge Greatest relevant down but cannot is provided Diameter Height Length Lumen Diameter measurement of delete or edit Needle Gauge Second Greatest Diameter the medical Third Greatest Diameter Total Volume device Width Size Value Numeric value Enter numeric Can add after 1 Required if Numeric 40 N A for the clinically value Grace Period Size is provided relevant size but cannot measurement of delete or edit the medical device Size Unit of The unit of Choose a value Can add after 13 Numeric 20
201. oyed into the GDSN Schema in 2016 17 into a final solution The GDSN attribute groupedProduct is a code list attribute It is used to specify if an item is a kit or a combination product A value populated for the GDSN attribute groupedProduct of KIT will populate a value of TRUE for the GUDID attribute Kit Any other value or when no value is provided for the GDSN attribute will populate a value of FALSE for the GUDID attribute Kit This attribute will be used to provide several sets of information and as such may be repeated GUDID attributes using this group of attributes are Kit and Combination Product Issue 1 Apr 2014 All contents copyright GS1 Page 131 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 29 Combination Product FDA GUDID Description Indicates that the product is comprised of two or more regulated products that are physically chemically or otherwise combined or mixed and produced as a single entity packaged together as a single package or packaged separately for the intended use together as defined under 21 CFR 3 2 e At least one of the products in the combination product must be a device in this case Data
202. pening Keep Refrigerated 5 C and Consume Within 48 hours Drink Chilled Store in a Cool Dry Place Refrigerate After Opening Can Be Kept in the Fridge For 3 Months Sterilization Method Type s of sterilisation that may have been performed by the manufacturer if a trade item is sterile when it comes from the manufacturer Sterilisation refers to any process that effectively kills or eliminates LOGICAL POPULATION Logical transmissible agents such as BOOLEAN value of TRUE from the HIE es Ue oallisen etn Gocta List fungi bacteria viruses prions population of any value in and spore forms etc from a initialManufacturerSterilisation surface equipment foods medications or biological culture medium Some methods of sterilisation are through the application of heat radiation and ethylene LOGICAL POPULATION Logical Data Pool to default on outbound BOOLEAN value of TRUE from the message population of any value in initialSterilisationPriorToUse This is an indication of the type s of sterilisation that is initialSterilisationPriorToUse Code List feailllics t lza campleteciiay a healthcare provider prior to initial use of the healthcare trade item Sterilisation refers to Issue 1 Apr 2014 All contents copyright GS1 Page 49 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Data Element GS1 GDSN Attri
203. perate a down Grace Period system for the issuance of UDIs Primary DI An identifier that GS1 14 digit Cannot edit add 1 1 Numeric or N A Number is the main numeric value or delete after Required Alphanumeric primary lookup HIBCC 6 23 Grace Period 6 23 for a medical character characters device and alphanumeric meets the value ICCBBA requirements to 10 or 16 uniquely identify character a device through alphanumeric its distribution value and use The primary DI number will be located on the base package which is the lowest level of a medical device containing a full UDI Device Count Number of Enter a numeric Cannot edit add 1 1 Numeric 7 N A medical devices value or delete after Required in the base Grace Period package For example Base Package Box of 100 gloves Primary DI 101 Device Count 100 Issue 1 Apr 2014 All contents copyright GS1 Page 14 of 163 Unit of Use DI An identifier ara Can edit after GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 0 Required if Numeric or GS1 14 digit N A Number assigned to an numeric value Grace Period if device count is Alphanumeric individual HIBCC 6 23 Device Count gt greater than one 6 23 medical device character 1 characters when a UDI is alphanumeric not labeled on value ICCBBA the individual 10 or 16 device at th
204. period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 59 Sterilization Method FDA GUDID Description Indicates the method s of sterilization that can be used for this device Data Entry Notes Choose a value from the drop down Webtool Issue 1 Apr 2014 All contents copyright GS1 Page 162 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Edit Rules After Grace Period Can edit add or delete after Grace Period only if Yes was selected for Requires Sterilization Prior to Use before Grace Period Cannot add Sterilization Methods after Grace Period if No was selected for Requires Sterilization Prior to Use before Grace Period Required 1 Required if Requires Sterilization Prior to Use is marked Yes Data Type amp Length N A Entry List of Values LOV Sterilization Methods LOV Chlorine Dioxide Dry Heat Ethylene Oxide High Intensity Light or Pulse Light Hydrogen Peroxide Microwave Radiation Moist Heat or Steam Ozone Peracetic Acid Radiation Radiation Sound Waves Ultraviolet Light New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name initialSterilisationPriorToUse Definition This is an indication of the type s of sterilisation that is required to be completed by a healthcare pr
205. r Database GUDID Implementation Guide This attribute is a Boolean clarifying how the item is controlled It is not for the population of actual lot or batch numbers Neither the GUDID nor GDSN are used to provide actual Batch or Lot numbers These should be communicated in transactional documents such as packaging shipping and invoice documents A value populated of TRUE signifies that the device has as one of its controls a batch or lot number It also signifies that the batch or lot number will be printed on the packaging and in the UDI 41 Manufacture Date FDA GUDID Description Flag to indicate the device is managed by date of manufacture the date a specific device was manufactured Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Can edit after Grace Period Required 1 1 Required Data Type amp Length Boolean Entry List of Values LOV Yes No New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment isTradeltemManagedByManufactureDate Definition Indication whether the trade item is managed by manufacture date A positive response indicates the manufacturer utilizes the manufacture date to control the item instead of lot and batch numbers Data Type Boolean GDSN Required Optional Final Deployment Attribute Name tradeltemDateOnPackagingT ypeCode coming in Major Release in 2016 Definition Indicates the type o
206. r delete after Grace Period Required 1 Required if there is a Secondary DI Number Data Type amp Length Alphanumeric 30 Entry List of Values LOV GS1 HIBCC ICCBBA NHRIC New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name additionalTradeltemldentificaton type Definition Type of the identification system that is being used as an alternative to the Global Trade Item Number Data Type Code List GDSN Required OPTIONAL Multiple Occurrence Population Guidance below The GS1 General Specifications stipulate that a Trade Item can only have one GTIN As the GTIN is the primary DI for an item using GDSN to provide data to the GUDID a GTIN using GS1 as the issuing agency can not be a secondary DI However the item might have another issuing agency s item number standard in _ use Using the GDSN attribute additionalTradeltemldentificaton type these other issuing agency identifiers can be provided Currently the GDSN attribute has code values for other issuing agencies which would have an associated additionalTradeltemldentificaton value provided to the GUDID If a value is populated through GDSN for an issuing agency using the attribute additionalTradeltemldentificaton type it will be provided to the GUDID as a secondary DI The codes available for the Secondary DI Issuing Agency are HIBC and ICCBBA The population of one of these additionalTradeltemldentificaton type values will denote the appropriate
207. r regulatory filings within the target market Data Type Boolean GDSN Required Optional Population Guidance below This value should default to FALSE unless a Labeler has an exemption and specifically changes the flag to TRUE This attribute is a temporary attribute AVP in GDSN It will be deployed into the GDSN Schema in 2016 17 into a final solution 16 DPM DI Different from Primary DI FDA GUDID Description Indicates that the DM DI Number is different than the Primary DI Number Data Entry Notes Select checkbox if appropriate WebTool Edit Rules After Grace Period Can add or delete after Grace Period Required 0 1 Not Required Data Type amp Length Boolean Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name N A Definition N A Data Type N A GDSN Required N A Population Guidance below LOGICAL POPULATION Logical BOOLEAN value of TRUE from the population of a value of DIRECT_PART_MARKING in GDSN Attribute additionalTradeltemldentification type This GUDID attribute is a Boolean and as such requires a TRUE or FALSE flag as a value If there is a value populated for the GDSN attribute combination of additionalTradeltemidentificaton type of DIRECT_PART_MARk and an associated additionalTradeltemldentificaton value then the logical value for the GUDID is TRUE else this value is FALSE Issue 1 Apr 2014 All contents
208. rUsageStoragelnstructions Definition Expresses in text the consumer storage and usage instructions of a product which are normally held on the label or accompanying the product This information may or may not be labelled on the pack Instructions may refer to a suggested storage temperature a specific storage requirement or a reference to environment or duration Examples include Refrigerate After Opening Consume within 4 days Keep Out Of Direct Sunlight Store at an Ambient Temperature Store in a Clean Cool Dry Place Store Away From Sunlight Strong Odours and Chemicals Keep in a Clean Cool Dry and Odourless Place Away From Direct Sunlight and Freezing Temperatures Keep in a Clean Cool Dry and Odourless Place Away From Direct Sunlight Before opening store at 5 C 30 C After Opening Keep Refrigerated 5 C and Consume Within 48 hours Drink Chilled Store in a Cool Dry Place Refrigerate After Opening Can Be Kept in the Fridge For 3 Months Data Type Text Language qualified 1 1000 characters GDSN Required OPTIONAL Population Guidance below This attribute can be populated with any special storage transportation or handling instructions as deemed necessary by the supplier manufacturer 57 Device Packaged as Sterile FDA GUDID Description Indicates the medical device is free from viable microorganisms See ISO TS 11139 Data Entry Notes C
209. rom FREE_FROM_LATEX The item is physically marked being natural rubber latex free from Latex rubber as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_LEGUME The item is physically marked as natural rubber latex _PROTEIN being free from legume protein as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_MILK The item is physically marked as natural rubber latex being free from milk and any of its derivates as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_MILK_PR Free from milk protein natural rubber latex OTEIN Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_NATURA The item is physically marked as Issue 1 Apr 2014 All contents copyright GS1 Page 60 of 163 FDA GUDID Attribute Code Value natural rubber latex GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value L_GLUTEN where needed Definition being naturally free from gluten and not extracted as part of the manufacturing process as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_PEANUT Marks if th
210. rrently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code FSK Flask Flask Issue 1 Apr 2014 All contents copyright GS1 Page 75 of 163 FDA GUDID Attribute Code Value GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition Packaging Type GDSN utilizes the Packaging Type Code FWR Forward Reel Forward Reel code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type GDSN utilizes the Packaging Type Code GBG Bag In Box or BIB Bag In Box or BIB is a type of code value however container for the storage and GUDID currently transportation of liquids It consists of needs a term for the a strong bladder usually made of code The term in aluminium PET film or other plastics the description field seated inside a corrugated fibreboard at right should be box The box and internal bag can be passed to the FDA fused GUDID Packaging Type GDSN utilizes the Packaging Type Code GBR Brick Brick A rectangular shaped code value however stackable package designed primarily GUDID currently for liquids such as juice or milk needs a term for the code The term in the description field at right should be passed to t
211. rue This effective date can be used for initial trade item offering or to mark a change in the in formation related to an existing trade item This date would mark when these changes take effect Data Type Date Time CCYY MM DDTHH MM SS GDSN Required MANDATORY Population Guidance below For GDSN most data pools will auto populate this date for the manufacturer However if a date is populated that date will not be overwritten The Labeler will need to pay particular attention to this date On this date the device information will be published by the FDA to the public GUDID site Once published a 7 day grace period begins Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be changed Many of the data elements are locked and can no longer be edited 13 Commercial Distribution End Date mm dd yyyy FDA GUDID Description Indicates the date the device is no longer held or offered for sale See 21 CFR 807 3 b for exceptions The device may or may not still be available for purchase in the marketplace Data Entry Notes Choose date from calendar or manually enter in format mm dd yyyy
212. s are those that support or sustain human life are of substantial importance in preventing impairment of human health or which present a potential unreasonable risk of illness or injury Due to the level of risk associated with Class IIl devices FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class Ill devices Therefore these devices require a premarket approval PMA application under section 515 of the FD amp C Act in order to obtain marketing clearance Please note that some Class Ill pre amendment devices may require a Class Ill 510 k See Historical Background2 for additional information Data Type Text GDSN Required Optional Final Deployment Attribute Name exemptFromFDAPreMarketAuthorization Definition Device is exempt from FDA Premarket regulations Premarket approval PMA is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class Ill medical devices Class Ill devices are those that support or sustain human life are of substantial importance in preventing impairment of human health or which present a potential unreasonable risk of illness or injury Due to the level of risk associated with Class IIl devices FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class Ill devices Therefore these devices require a premarket approval PMA application und
213. sion rights and accountability of the key pillars Executive Internal sponsors of the Master Data Management process within an organization executive management Legal Legislative Internal sponsors responsible for the representation of regulatory affairs as it relates to information management and publication in both internal and external systems and databases This includes legal compliance legislative and regulatory requirements This is especially important with UDI regulation Administrative Internal function responsible for the maintenance of the Master Data The function can be either centralized or decentralized Refer to the Roles and Responsibilities section of this document for more information in functional responsibilities Roles and Responsibilities The Data Governance policies should include clear determination documentation and enterprise wide education of the Roles and Responsibilities of each function across the information supply chain This should include a determination of how data is managed within an organization and the roles associated with the process Generally speaking there are two overarching models centralized or decentralized Most commonly the responsibilities are spread across an entire organization ranging from manufacturing to product management to regulatory affairs Which model applies to a particular organization depends on many factors such as organizational structure size and policies rel
214. sting GS1 members The UDI regulation may contain specific information related to the rule which in case of conflict supersedes this general guidance 1 3 Prerequisite It is assumed that the reader is already familiar with the UDI regulation and the database requirements prior to using this implementation guide For additional information on UDI visit the GS1 UDI webpage or the website of the specific regulation in question Below are a few basics steps the Medical Device manufacturer should consider prior to using the GDSN to register their medical device product data in the appropriate UDI database The section includes prerequisites for using GS1 standards to implement a UDI regulation 1 3 1 The GS1 Global Company Prefix GCP The GS1 Global Company Prefix is the base component used to create a GS1 Key such as a Global Trade Item Number GTIN The GS1 Global Company Prefix is a license to create GS1 Keys and is issued by any one of the GS1 Member Organisations to companies who wish to use the GS1 system The GS1 website lists 10 basic steps to bar code implementation and is offered as a guide for getting started For additional information regarding your GS1 Company Prefix and GS1 standards contact your local GS1 Member Organisation by visiting the GS1 website 1 3 2 Role the Global Trade Item Number GTIN and Application Identifiers Als The Global Trade Item Number GTIN as the GS1 trade item Identification Key is used
215. subjected The minimum atmospheric pressure in which the item should be transported to remain usable This value is the value below which the trade item should not be subjected GDSN Notes GUDID Code for Storage Type Storage environment temperature AVP transportationEnvironmentAtmosphericP ressureMaximum AVP transportationEnvironmentAtmosphericP ressureMinimum transportationEnvironmentAtmospheric PressureMaximum UoM transportationEnvironmentAtmospheric PressureMinimum UoM Numeric Code List Numeric Code List The maximum atmospheric pressure in which the item should be transported to remain usable This value is the value above which the trade item should not be subjected The minimum atmospheric pressure in which the item should be transported to remain usable This value is the value below which the trade item should not be subjected AVP transportationEnvironmentAtmosphericP ressureMaximum AVP transportationEnvironmentAtmosphericP ressureMinimum transportationHumidityMaximum UoM Numeric Code List The maximum humidity in percentages in which the trade items should be transported AVP transportationMaximumHumidityMaximum transportationHumidityMinimum UoM Numeric Code List The minimum humidity in percentages in which the trade items should be transported AVP transportationMaximumHumidityMinimum transportationHumidityMaximum UoM Numeric
216. system of weights and a small unit of volume This unit is called more correctly fluid dram or in contraction also fluidram The fluid dram is defined as 1 8 of a fluid ounce which means it is exactly equal to 3 551 632 812 500 0 mL in the Commonwealth and Ireland In England dram came to mean a small draught of cordial or alcohol hence the term dram house for the taverns where one could purchase a dram UoM Pending UoM UN DS Display Recommendation 20 UoM Pending UoM UN E14 Kilocalorie A unit of energy equal to 1000 Recommendation 20 international table calories UoM Pending UoM UN E37 Pixel A unit of count defining the number of Recommendation 20 pixels pixel picture element UoM Pending UoM UN E39 Dots per inch A unit of count defining the number of Recommendation 20 dots per linear inch as a measure of the resolution or sharpness of a graphic image UoM Pending UoM UN ELU ELISA Units Enzyme linked immunosorbent assay Recommendation 20 unit is always associated with a product and a method UoM Pending UoM UN EV Envelope Recommendation 20 UoM Pending UoM UN FH Micromole One millionth 10 6 of a mole Recommendation 20 UoM Pending UoM UN FJ Sizing Factor Commonly used to specify an order Recommendation 20 sizing factor related to a trade item to allow standard condition brackets for a variety of items Different items or different configuration of an item may be assigned different points e g an individual it
217. t Pound per square The Fahrenheit temperature scale the freezing point of water is 32 degrees Fahrenheit F and the boiling point 212 F at standard atmospheric pressure placing the boiling and freezing points of water exactly 180 degrees apart A non SI unit of Pressure Type Unit of Measure Recommendation 20 foot approximately equal to 47 88025 PASCAL s Contact Used to provide Contact Type CONSUMER_SUPPOR The party which provides product Contact Information 1 support to the end user of a trade for GUDID item or a service Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_EGG Marks if the product is free from egg natural rubber latex Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_FISH The item is physically marked as natural rubber latex being free from fish as approved by the appropriate authority of the target market Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_GLUTEN Marks if the product is free from natural rubber latex gluten This level of containment is frequently determined through regulation for example per EU Regulation EC No 41 2009 of 20 January 2009 this is defined as lt 20 mg kg Device labeled as Not made with FALSE packageMarksFreeFrom FREE_FROM_LACTOS Indicates if the amount of lactose is natural rubber latex E reduced Device labeled as Not made with TRUE packageMarksFreeF
218. t require the use of or but can enter these symbols Support Email for the Enter Can edit add or 1 Required if Alphanumeric N A Contact Email support contact alphanumeric delete after support contact 100 email address in Grace Period information is format entered Device Status Human Cell Indicates that the Check box if Can add or 0 1 Not Boolean N A Tissue or product contains appropriate delete after Required Cellular or or consists of Grace Period Tissue Based human cells or Product tissues that are HCT P intended for implantation transplantation infusion or transfer into a human recipient as defined under 21 CFR 1271 3 Kit Indicates that the Check box if DI Cannot add or 0 1 Not Boolean N A device is a record is for the delete after Required convenience kit itself Do not Grace Period combination in check if the vitro diagnostic product is part of IVD or medical a kit procedure kit Kits are a Issue 1 Apr 2014 All contents copyright GS1 Page 22 of 163 collection of products including medical devices that are packaged together to achieve a common intended use and is being distributed as a medical device GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Combination Product Indicates that the product is comprised of two or more regulated products that are physically chemical
219. t and Governance Master Data Management and Governance MDM amp G refers to a series of processes and protocols that should exist within an organisation to create enrich maintain and publish product information within and outside the enterprise Equally important is data quality management which is a complementary cycle of activities aimed to ensure that the subject information meets high standards of quality and reliability In short the data created by the product manufacturer must meet the requirements of the intended use case Medical device data which has to comply with UDI regulation is no exception Completeness and accuracy of product data is the responsibility of the manufacturer Each manufacturer should have an internal process to manage the data required by the regulator This includes a data quality checks and procedures data management process and policies enterprise wide data governance policies roles and responsibilities which outline who has the authority to create modify and approve the data GS1 strongly recommends that each manufacturer ensure they have a robust Information MDM amp G and data quality process in place as part of their internal data preparation process Issue 1 Apr 2014 All contents copyright GS1 Page 7 of 163 1 6 1 7 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Data Quality Good data quality is a key ingredient of any efficient suppl
220. t of Measure Pending UoM UN LM Linear metre A unit of count defining the number of Recommendation 20 metres in length of a uniform width object UoM Size Unit of Measure Pending UoM UN MMT Millimetre A millimetre is one thousandth of a Recommendation 20 metre 0 001 UoM Size Unit of Measure Pending UoM UN MTR Metre The metre is the basic unit of length in Recommendation 20 the International System of Units Sl UoM Size Unit of Measure Pending UoM UN NIU Number of A unit of count defining the number of Recommendation 20 International Units international units The International Unit is a unit of measurement for the amount of a substance based on measured biological activity or effect The unit is used for vitamins hormones some medications vaccines blood products and similar biologically active substances UoM Size Unit of Measure Pending UoM UN SET Set A unit of count defining the number of Recommendation 20 sets set a number of objects grouped together UoM Size Unit of Measure Pending UoM UN SMI Mile statute mile A statute mile of 5 280 feet exactly Recommendation 20 1 609 344 meters UoM Size Unit of Measure Pending UoM UN YRD Yard A yard is It is equal to 3 feet or 36 Recommendation 20 inches or 0 9144 meter UoM Storage and Handling Pending UoM UN 28 Kilogram per A unit of pressure equal to Type Unit of Measure Recommendation 20 square metre 9 80665 10 05 Bar UoM Storage and Handling Pending UoM UN BAR Bar unit of
221. t right should be passed to the FDA GUDID Packaging Type Code BRG Barge Barge Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BSK Basket or hamper Basket or hamper A semi rigid container usually open at the top traditionally used for gathering shipping and marketing agricultural products Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BXI Box with inner container Box with inner container Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code BXT Bucket Bucket A container usually cylindrical can be equipped with a lid and a handle e g a pail made of metal plastic or other appropriate material Issue 1 Apr 2014 All contents copyright GS1 Page 67 of 163 FDA GUDID Attribute Code Value Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN for the F
222. t should be passed to the FDA GUDID Packaging Type Code CNE Container Engine Container Engine Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CNF Container Multi walled Secured to Warehouse Pallet Container Multi walled Secured to Warehouse Pallet Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CNT Container Container Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code COL Coil Coil Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code CON Cones Cones Issue 1 Apr 2014 All contents copyright GS1 Page 71 of 163 FDA GUDID Attribute Code Value Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID
223. ta Type amp Length The type of value for the element Boolean Text Code List etc including how many characters are available for population Entry List of Values This is a list of values which can be provided for code list attributes LOV New DI Trigger Indicator signifying if a change to this data element would trigger a new Device Identifier to be created In GS1 Standards this indicates if anew GTIN should be created due to a change in the value for this element Public Private Status Indicator signifying if this element will be posted on the FDA GUDID public facing website PUBLIC or for FDA consumption only PRIVATE Document reference The FDA term GS1 14 digit numeric value is equal to a GTIN a The FDA term Primary DI in GS speak would be the primary device GTIN For example a DI 101 is the Primary GTIN and Dis 201 and 301 would be the packaging levels Issue 1 Apr 2014 All contents copyright GS1 Page 13 of 163 When a GUDID attribute appears on the m GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide edical device package label the values submitted to the GU DID should match the value on the label Device Information Device Identifier DI Information Issuing Agency Organization Choose a value Cannot edit add 1 1 Alphanumeric GS1 HIBCC ICCBBA accredited by from the drop or delete after Required 30 FDA to o
224. tached to an item In electronics this number is typically found around or near a serial number Issue 1 Apr 2014 All contents copyright GS1 Page 50 of 163 Catalog Number FDA GUDID Attribute Code Value GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Additional Trade Item Identification Type Code Value SUPPLIER_ASSIGNED Description where needed Definition Current definition The additional Trade Item Identification value populated has been developed and assigned by the party which provides service s and or manufactures or otherwise has possession the goods and consigns or makes them available in trade Definition for GDSN Major Release 3 x in 2016 The additional Trade Item Identification value populated has been developed and assigned by the party which provides service s and or manufactures or otherwise has possession of the goods and consigns or makes them available in trade This number is a base model or style number assigned to the product and may be the same for several GTINs where they are variations of each other For example a coffee mug with 3 GTINs one each for the brown mug the white mug and the black mug might all be the supplier assigned number of AB123 Use of this value is recommended in the absence of a Model Number or Manufacturer s Part Number Type Unit of Measure UoM Storag
225. te CCYY MM effectiveDate DDTHH MM SSs Indicates the latest date that the trade item can be shipped This is independent of any specific ship from location Date Time CCYY MM Alternative or Additional Identifiers Issue 1 Apr 2014 All contents copyright GS1 Page 35 of 163 BY 1 0 B DEDEGE SEA Direct Marking DM GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Name GDSN Data Type GDSN Definition GDSN Notes isTradeltemExemptFromDirectPartMark ing Boolean directPartMarking Text Indicator signifying the trade item is exempt from direct identification marking according to regulation or regulatory filings within the target market This is a number or marking placed directly on the medical device AVP isTradeltemExemptFromDirectPartMarki ng AVP directPartMarking Secondary DI additionalTradeltemldentificationType Code List Type of the identification system that is being used as an alternative to the Global Trade Item Number additionalTradeltemldentificationValue Code List Alternative means to the Global Trade Item Number to identify a trade item Package DI globalTradeltemNumber use hierarchy to obtain parent child information Numeric 14 Characters Can add Package Configuration after Grace Period but cannot delete or edit Package
226. ted for a particular change All changes must meet the requirements of the Quality System regulation Good Manufacturing Practices under 21 CFR Part 820 including the design control requirement under 820 30 Changes for which an applicant AVP fDASupplementNumber External Code managed by FDA Should be multiple occurrence fDASupplementNumber Code List Issue 1 Apr 2014 All contents copyright GS1 Page 39 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN Definition GDSN Notes must submit a PMA supplement include but are not limited to the following types of changes if they affect the safety or effectiveness of the device new indication for use of the device labeling changes the use of a different facility or establishment to manufacture process sterilize or package the device changes in manufacturing facilities methods or quality control procedures changes in sterilization procedures changes in packaging changes in the performance or design specifications circuits components ingredients principles of operation or physical layout of the device and extension of the expiration date of the device based on data obtained under a new or revised stability or sterility testing protocol that has not been approved by FDA If the protocol has been previously approved by F
227. temNumber Characters Numeric Code List netContent UoM GDSN Definition GDSN Notes EAN UCC numbering structures will be used for the identification of trade items All of them will be considered as 14 digit Global Trade Item Number GTIN Must be present to enable data to be presented to trade item catalogue Must be submitted by the owner of the data who may be the original manufacturer the importer the broker or the agent of the original manufacturer This field is mandatory within the Global Data Synchronization work process The amount of the trade item contained by a package usually as claimed on the label For example Water 750ml net content 750 MLT 20 count pack of diapers net content 20 ea In case of multi pack This GTIN should be the lowest level fors the hierarchy Issue 1 Apr 2014 All contents copyright GS1 Page 33 of 163 1 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN Definition GDSN Notes indicates the net content of the total trade item For fixed value trade items use the value claimed on the package to avoid variable fill rate issue that arises with some trade item which are sold by volume or weight and whose actual content may vary slightly from batch to batch In case of variable quantity trade items indicates the average
228. the FDA Global Unique Device Identifier Database GUDID Implementation Guide The FDA will automatically populate the GUDID with a value for this attribute based on the Code GMDN submitted Publishing the description field with the classification code name or description will provide additional value to supply chain partners receiving the message The population of a GMDN Code via GDSN has been available for some time While the FDA will not make the code available to the Public in the GUDID GDSN will pass the code along to normal GDSN recipients for their use following their existing processes 38 Definition FDA GUDID Description Description associated with the GMDN Preferred Term Code Data Entry Notes System populated based on GMDN Preferred Term Code Edit Rules After Grace Period N A Required 1 1 Required Data Type amp Length Alphanumeric Entry List of Values LOV GMDN list New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name N A Definition N A Data Type N A GDSN Required 1 1 Required Population Guidance below The FDA will automatically populate the GUDID with a value for this attribute based on the Code GMDN submitted 39 For Single Use FDA GUDID Description Indicates that the device is intended for one use or on a single patient during a single procedure Data Entry Notes Choose a value from the drop down Webtool Edit Rules After Grace Period Cannot edit after Grace Period
229. thin a given packaging configuration For example Package configuration Carton with Package Dl 201 contains 4 boxes of the base package Dl 101 the quantity per package is 4 Issue 1 Apr 2014 All contents copyright GS1 Page 122 of 163 globalTradeitemNum __ tradeltemUnitDescrip GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Package configuration Case with Package DI 301 contains 5 cartons of Package DI 201 the quantity per package is 5 Package configuration Carton with Package Dl 202 contains 10 boxes of the base package Dl 101 the quantity per package is 10 Data Entry Notes The quantity of a package configuration needs to be greater than 1 Edit Rules After Grace Period Can add with new package configuration after Grace Period but cannot delete Required 0 Required if Package Configuration is entered Data Type amp Length Numeric 9 Entry List of Values LOV N A New DI Trigger NO Public Private Status Public GS1 GDSN Attribute Name quantityofNextLowerLevelTradeltem Definition The number of one child trade item as identified by the association of ChildTradeltem class to Tradeltemldentification class contained by the parent trade item The child trade item must be in the hierarchy level immediately below the parent trade item Data Type Integer GDSN Required DEPENDENT not populated where isTradeltemABaseUnit is TRUE Population Guidance below The GUDID
230. tion 20 Square Meter UoM Pending UoM UN B8 Board Recommendation 20 UoM Pending UoM UN BA Bale Recommendation 20 UoM Pending UoM UN BD Bundle Recommendation 20 UoM Pending UoM UN BG Bag Recommendation 20 UoM Pending UoM UN BN Bulk Recommendation 20 UoM Pending UoM UN BO Bottle Recommendation 20 UoM Pending UoM UN BQ Becquerel The becquerel symbol Bq is the SI Recommendation 20 derived unit of radioactivity One Bq is defined as the activity of a quantity of radioactive material in which one nucleus decays per second SI uses the becquerel rather than the second for the unit of activity measure to avoid dangerous mistakes a measurement in becquerels is proportional to activity and thus a more dangerous source of radiation gives a higher reading A measurement in seconds is inversely proportional UoM Pending UoM UN BQL Becquerel The becquerel symbol Bq is the SI Recommendation 20 derived unit of radioactivity One Bq is defined as the activity of a quantity of radioactive material in which one nucleus decays per second SI uses the becquerel rather than the second for the unit of activity measure to avoid dangerous mistakes a measurement in becquerels is proportional to activity and thus a more dangerous source of radiation gives a higher reading A measurement in seconds is inversely proportional UoM Pending UoM UN BX Box Recommendation 20 UoM Pending UoM UN C18 Millimole a millimole is one thousandth of a
231. tion Guide FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN Definition GDSN Notes that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices Therefore these devices require a premarket approval PMA application under section 515 of the FD amp C Act in order to obtain marketing clearance Please note that some Class III preamendment devices may require a Class III 510 k See Historical Background2 for additional information Text name of the additional external classification agency whose schema is being additionalClassificationCategoryAgency Code List pie pea eceiton i tre Global EAN UCC schema Use code of Required if additional FDA_510K_PREMARKET_NOTIFICATI classification schema fields ON when available in GDSN are populated AVP fDA510KPremarketAuthorization Category code based on External Code managed by FDA alternate classification additionalClassificationCategoryCode Text 1 15 characters schema chosen in addition to EAN UCC classification schema Number associated with the regulatory decision regarding the applicant s legal right to market a medical device PMA Supplement After FDA has approved a PMA an applicant must submit a PMA supplement for review and approval by FDA before making any change affecting the safety or effectiveness of the device unless FDA has advised that an alternate type of submission is permit
232. to this field If selected NO to Device required to be labeled as containing natural rubber latex or dry natural rubber 21 CFR 801 437 can add or delete check to this field 0 1 Not Required Boolean N A Prescription Status require a prescription to Grace Period Prescription Indicates that the Select check box Can add or 0 1 Not Boolean N A Use Rx device requires a if appropriate delete after Required prescription to Grace Period use Over the Indicates that the Select check box Can add or 0 1 Not Boolean N A Counter OTC device does not if appropriate delete after Required Issue 1 Apr 2014 All contents copyright GS1 Page 28 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide use and can be purchased over the counter OTC MRI Safety Status Is the device Indicates that Check box if Can add check 0 1 Not Boolean N A labeled for MRI sufficient testing appropriate to checkbox after Required Safety has been Grace Period conducted to but cannot characterize the delete a check behavior of the from the device in the MR checkbox environment See ASTM F2503 13 MRI Safety Indicates the MR Must select one Can add MRI 1 Required if N A MR Safe MR Unsafe MR Conditional Status safety status of value from drop Safety Status selected check the device The three drop d
233. ts copyright GS1 Page 54 of 163 FDA GUDID Attribute Code Value GS1 GDSN Attribute Code Value Description GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide Definition where needed here is used somewhat incorrectly as density is mass by volume More precisely it is a measure of the area density areal density or surface density UoM Pending UoM UN GRM Gram A gram is defined as one one Recommendation 20 thousandth of the kilogram 1x10 3 kg UoM Pending UoM UN GRN Grain A grain or troy grain is precisely Recommendation 20 64 79891 milligrams Exactly 7 000 grains per avoirdupois pound UoM Pending UoM UN GRO Gross A unit of count defining the number of Recommendation 20 units in multiples of 144 12 x 12 UoM Pending UoM UN GWH Gigawatt hour A gigaawatt hour is 109 kilowat hour Recommendation 20 or 3 6 terajoules UoM Pending UoM UN HC Hundred count A unit of count defining the number of Recommendation 20 units counted in multiples of 100 UoM Pending UoM UN HD Half dozen A unit of count defining the number of Recommendation 20 units in multiplt of six 6 UoM Pending UoM UN HGM Hectogram A hectogram is one hundred 100 Recommendation 20 grams UoM Pending UoM UN HLT Hectolitre A hectolitre is one hundred 100 Recommendation 20 litres UoM Pending UoM UN HTZ Hertz A unit of frequency defined as the Recom
234. tt hour A kilowatt hour is a unit of energy Recommendation 20 equal to 3 6 megajoules It is also a common commercial unit of electric energy representing the amount of energy delivered at a rate of 1 000 watts over a period of one hour UoM Pending UoM UN KWT Kilowatt A kilowatt is one thousand 1000 Recommendation 20 watts UoM Pending UoM UN LBR Pound The international avoirdupois pound Recommendation 20 of exactly 0 45359237 kilogram UoM Pending UoM UN LR Layer A unit of count defining the number of Recommendation 20 layers UoM Pending UoM UN LTN Ton UK or long Ton UK 1016 Kg or 2240 Lb Recommendation 20 ton US UoM Pending UoM UN LTR Litre A litre is defined as a special name for Recommendation 20 a cubic decimetre 1 L 1 dm3 103 cm3 UoM Pending UoM UN MAW Megawatt A unit of power defining the rate of Recommendation 20 energy transferred or consumed when a current of 1000 amperes flows due to a potential of 1000 volts at unity power factor UoM Pending UoM UN MC Microgram A microgram is one millionth of a Recommendation 20 gram 0 000001 UoM Pending UoM UN MGM Milligram A milligram is one thousandth of a Recommendation 20 gram 0 001 UoM Pending UoM UN MHZ Megahertz A unit of frenquecy equal to 106 Hertz Recommendation 20 UoM Pending UoM UN MIK Square mile A square mile is an area of a square Recommendation 20 whose sides are exactly 1 mile in length UoM Pending UoM UN MIN Minute unit of A minute is
235. ules The watt hour is rarely used to express energy in any form other than electrical UoM Pending UoM UN WTT Watt A watt is a derived unit of power one Recommendation 20 watt is equivalent to 1 joule J of energy per second UoM Pending UoM UN YDK Square Yard A square yard is the area of a square Recommendation 20 with sides of one yard three feet thirty six inches 0 9144 metres in length UoM Size Unit of Measure Pending UoM UN 5B Batch A unit of count defining the number of Recommendation 20 batches batch quantity of material produced in one operation or number of animals or persons coming at once UoM Size Unit of Measure Pending UoM UN AS Assortment A unit of count defining the number of Recommendation 20 assortments assortment set of items grouped in a mixed collection UoM Size Unit of Measure Pending UoM UN CMT Centimetre A centimetre is equal to one Recommendation 20 hundredth of a metre UoM Size Unit of Measure Pending UoM UN DMT Decimetre A decimetre is equal to one tenth of a Recommendation 20 metre UoM Size Unit of Measure Pending UoM UN DZN Dozen A unit of count defining the number of Recommendation 20 units in multiples of 12 UoM Size Unit of Measure Pending UoM UN E27 Dose A unit of count defining the number of Recommendation 20 doses dose a definite quantity of a medicine or drug UoM Size Unit of Measure Pending UoM UN E55 Use A unit of count defining the number of Recommendation 20 times an obj
236. value changes This GUDID attribute is a Code List clarifying the qualifier type associated to the clinical size values For example as syringe is measured by the gauge of the needle and or the volume it can contain For the type this attribute might be populated with NEEDLE GAUGE and or TOTAL_VOLUME This attribute is part of a repeatable class of clinical attributes for the device containing the Size Type Size Value and Size Unit of Measure for the device s clinical size There is an option to specify a textual value for a clinical size type which has not been specified in the value and UoM attributes When this attribute is published with the value of DEVICE_SIZE_TEXT SPECIFY the GDSN attribute clinicalSizeText becomes required Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can be added but can not be edited or deleted 51 Size Value FDA GUDID Description Numeric value for the clinically relevant size measurement of the medical device Data Entry Notes Enter numeric value Edit Rules After Grace Period Can add after Grace Period but cannot delete or edit Required 1 Required if Size is provided Data Type amp Length Numeric 1 40 digits Entry List of Values LOV New DI Trigger NO Public Private Status Public GS1 GDSN Temporary population until final GDSN deployment clinicalSizeValue Issu
237. vided Hierarchy Number 1 gt ChildTradeltem glob quantityofNextLow globalTradeitemNumber tradeltemUnitDescriptor Aeddi erLevelTradeltem 2061414111111c CASE 1061414111111c 5 5 cartons in a case 1061414111111c Gana asi 0061414111111c 4 4 boxes in a carton 0061414111111c PASEON T OR FAG N A N A 1 Box of Gloves Hierarchy Number 2 ChildTradeltem glob quantityofNextLow globalTradeitemNumber tradeltemUnitDescriptor altieagtal tera Nhialsen erLevelTradeltem 4061414111111 CASE 3061414111111 2 2 cartons in a case 3061414111111 PACK_OR_INNER_PACK 0061414111111c 10 10 boxes in a carton 0061414111111 BASE_UNIT_OR_EACH N A N A 1 Box of Gloves This is converted to the following for population in the GUDID Package DI Number Quantity per package Contains DI Package 1061414111111c 4 0061414111111c Indicates there are 4 eaches in the pack 2061414111111c 5 3061414111111c Indicates there are 5 packs in the case 3061414111111c 10 0061414111111c Indicates there are 10 eaches in the pack 4061414111111 2 3061414111111c Indicates there are 2 packs in the case Once published a 7 day grace period begins During the grace period most attributes can be edited After the grace period ends on day 8 this attribute can not be deleted 21 Quantity per package FDA GUDID Description The number of packages with a unique primary DI wi
238. x Can add or 0 1 Not Boolean N A to Direct exempt from if appropriate delete after Required Marking DM Direct Marking Grace Period but Exempt requirements under 21 CFR 801 45 DM DI Different Indicates that the Select checkbox Can add or 0 1 Not Boolean N A from Primary DI DM DI Number is if appropriate delete after Required different than the Grace Period Primary DI Number DM DI Number An identifier that GS1 14 digit Can edit add or 0 Required Numeric or N A is marked numeric value delete after only if check box Alphanumeric directly on the HIBCC 6 23 Grace Period for DM DI 6 23 medical device character Different from characters and is different alphanumeric Primary DI than the Primary value ICCBBA DI Number only 10 or 16 applicable to character devices subject alphanumeric to Direct Marking value requirements under 21 CFR 801 45 Secondary DI Secondary DI Name of Choose from Cannot edit add 1 Alphanumeric GS1 HIBCC ICCBBA NHRIC Issuing Agency Issue 1 Apr 2014 Secondary DI Issuing agency drop down or delete after Grace Period Required if there is a Secondary DI Number All contents copyright GS1 30 Page 18 of 163 Secondary DI An identifier that Cannot edit add GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide 1 Required if Numeric or Issue 1 Apr 2014
239. y chain In this context the GTIN for the current item which is a child item of another item childGTIN Numeric 14 Characters The code identifying the type packaging TypeCode Text 1 3 characters of package used as a container of the trade item System generated text description of the type of packaging used for the trade item packaging TypeDescription Text 1 70 characters Communicate the date on which the trade item is no longer to be manufactured Allows the reuse of the GTIN discontinuedDate DateTime after 48 months with the explicit exception of Apparel being 30 months and the implicit exception for specialty products e g steel beams Support Contact Value populated for the contact The general category of the ntormation iS tha contactType Code List E Aas eae item LICENSEE_ REGISTRAR or 9 CUSTOMER_SUPPORT Means used to communicate Value populated for the support contact communicationChannelCode Code List with another party phone number is TELEPHONE Issue 1 Apr 2014 All contents copyright GS1 Page 37 of 163 GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide FDA GUDID Data Element GS1 GDSN Attribute Name GDSN Data Type GDSN Definition GDSN Notes Number assigned to a communicationNumber Text 1 70 characters specific means of communication Means used to communicate Value populated for the support cont
240. y chain Having the means to continuously maintain high quality data is not only vital to reducing errors and improving patient safety but also to reducing errors in the supply chain It is also fundamental to increasing efficiency reducing costs and positively impacting customer satisfaction Good quality data means that all master data is complete consistent accurate time stamped and industry standards based By improving the quality of data trading partners reduce costs improve productivity and accelerate speed to market For more information on GS1 data quality best practices and recommendations refer to the Data Quality page on the GS1 website Some regulators may include specific business and data validations to ensure data quality of the information provided by the manufacturer Please refer to the specific regulation for more information Data Management Data Management refers to processes and procedures within an enterprise related to lifecycle information management In relationship to UDI regulation this refers to product master data and lifecycle management of the related information The U S FDA regulation contains specific data management requirements and recommendations to which a manufacturer must adhere However this section contains general guidance as a recommendation to augment the requirements of any regulator In case of conflict the regulation supersedes this guidance Below are seven basic steps of an information
241. ype Code CMS CNA Clamshell Household Goods Container Wood Clamshell Household Goods Container Wood Packaging Type Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at right should be passed to the FDA GUDID Packaging Type Code Packaging Type Code CNB CNC Container MAC ISO LT WGT 8x8x20 Foot Air Container Navy Cargo Transporter Container MAC ISO LT WGT 8x8x20 Foot Air Container Navy Cargo Transporter Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in Packaging Type Code CND Container Commercial Highway Lift Container Commercial Highway Lift Issue 1 Apr 2014 All contents copyright GS1 Page 70 of 163 FDA GUDID Attribute Code Value the description field at right should be passed to the FDA GUDID GDSN for the FDA Global Unique Device Identifier Database GUDID Implementation Guide GS1 GDSN Attribute Code Value Description where needed Definition Packaging Type GDSN utilizes the code value however GUDID currently needs a term for the code The term in the description field at righ
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