Regulatory Open Forum

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  • 1.  GUDID Private Label confidentiality

    Posted 07-Dec-2023 18:44

    Hello Forum,

    As the device manufacturer (produce, package, and label the device) who enters the GUDID data, how do we keep our private labeler's brand name confidential, please?



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    Tim White
    RA Manager
    Frisco TX
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  • 2.  RE: GUDID Private Label confidentiality

    Posted 09-Dec-2023 10:09

    Hello Tim

    If they have asked you to label the device with their name and not yours, to maintain confidentiality, then they should also have their company name as the labeler in GUDID. The UDIs themselves (e.g. GTINs or HIBCC prefix) should also belong to that company.

    When a user with the device in hand goes to AccessGUDID to look it up, the information they find should match the product labeling.



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    Anne LeBlanc
    United States
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