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Leveraging GDSN for the FDA Global Unique Device Identifier Database (GUDID) Implementation Guideline Description Indicates the device is managed by a Donation Identification Number. This number can be found on the device label or packaging. The Donation Identification Number is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation. Data Type & Length Type: Boolean Entry List of Values (LOV) Yes/No New DI Trigger? YES Public/Private Status Public GS1 GDSN Module AVP Content Attribute/Role donationIdentificationNumberMarked Datatype/Secondary Class Boolean Multiplicity Optional Occurrence Single Definition Indicates the device is managed by a Donation Identification Number. This number can be found on the device label or packaging. The Donation Identification Number is applicable to devices that are also regulated as HCT/Ps and is a number that is assigned to each donation. Code List Name N/A Population Guidance (below) This attribute has a temporary attribute (AVP) in GDSN- donationIdentificationNumberMarked. It will be deployed into the GDSN Schema in 2016-17 into a final solution. This GUDID attribute is a Boolean clarifying how the item is controlled. It is not for the population of actual Donation Identification Numbers. Neither the GUDID nor GDSN are used to provide actual Donation Identification Numbers. These should be communicated in transactional documents such as packaging, shipping and invoice documents. 6.46 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 Product Contains Natural Rubber Latex Which May Cause Allergic Reactions" or (4) "The Packaging of This Product Contains Dry Natural Rubber". Data Entry Notes Choose Yes/No from the drop down list. (Webtool) Edit Rules After Grace Period None (NO edit, add, or delete are allowed) Required? Required Data Type & Length Type: Boolean Entry List of Values (LOV) Yes/No New DI Trigger? YES Public/Private Status Public Release 2.0, Ratified, Oct 2015 © 2015 GS1 AISBL Page 195 of 218
