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  • 1.  UDI/GUDID transfer

    Posted 24-Feb-2017 15:47
    What are the requirements when Company A sells a business unit to Company B, where Company A has applied UDI labeling to devices, and entered them into the GUDID database?  Is there a smooth way to effect this transfer?  Once the sale is effective, is there some transitional period in regard to device labeling and GUDID entry?  What if Company B is a start-up and does not yet have a DUNS number?  Thanks, --Mitch

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    Mitchell Johnson, RAC(US)
    Arden Hills MN
    United States
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  • 2.  RE: UDI/GUDID transfer

    Posted 27-Feb-2017 11:44
    Hi, Mitch,

    Part of the answer depends on whether the Company A unit being sold has its own unique FDA accredited bar code issuing agency labeler code and range of unique numbers.  If those stay the same, the transfer will be much simpler.  The FDA UDI Help Desk can help you transfer those to your new account.  Otherwise Company B will have to purchase its own labeler code and range of numbers to create new Device Identifiers.  Company A's former owner would make their range of numbers for the products being transferred obsolete on the GUDID and Company B would have to use their own DI's on the product labels and enter the appropriate data into the GUDID.

    Will the legal manufacturer name and address stay the same?  Company B will have to request a new DUNS number and that address must match the manufacturer name and address on the label.  Again if the address and name are changing, the new label, GUDID entries, and DUNS number must reflect that.  The new DUNS number will also have to be registered with sam.gov or the GUDID will not recognize the DUNS number as valid.

    You will have to have the contact person, coordinator, and label data entry users identified with the new labeler account.  Most likely the customer contact and e-mail will change but these changes do not require new Device Identifiers (DI's).

    This FDA attribute table will help you see which GUDID attributes can be changed without new DI's:
    https://www.fda.gov/downloads/.../GlobalUDIDatabaseGUDID/UCM396592.xls

    This is not by any means a conclusive list (there is direct part marking and other things to be considered), but it will get you headed in the right direction.

    Good luck.

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    John Minier, RAC
    Director / Consultant
    Minier Medical Device Consulting
    john@johnminier.com
    Highland Mills, NY
    United States
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    Original Message


  • 3.  RE: UDI/GUDID transfer

    Posted 28-Feb-2017 09:26
    Hi Mitchell-
    It is very important to check with the issuing agency for completing the transfer with them.  
    For example, to continue use of GS1 GTINs, you would need to complete a "Company Prefix Transfer Request Form" and submit it to GS1 along with a Letter from the Seller releasing the Prefix. For more information see https://www.gs1us.org/what-we-do/membership/member-resources/mergers-acquisitions 
    I am not sure of the procedure for other issuing agencies.
    Continued Success,

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    Stacey Henning
    GUDID Coordinator, RA Advisor
    Cardinal Health
    Waukegan IL
    United States
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    Original Message


  • 4.  RE: UDI/GUDID transfer

    Posted 01-Mar-2017 11:35
    John, Stacey,

    Thank you each for your response.  This gives me a good starting point and direction.  I appreciate your insight.

    Mitch

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    Mitchell Johnson (RAC)
    Arden Hills MN
    United States
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    Original Message


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