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  • 1.  Basic-UDI-DI

    This message was posted by a user wishing to remain anonymous
    Posted 18-Nov-2019 09:31
    This message was posted by a user wishing to remain anonymous

    Hi, 

    Has anyone created Basic-UDI-DI for the Medical devices?

    What kind of process needs to be followed? If anyone has a sample basic UDI-DI which one can share that will be greatly appreciated.

    Thanks!


  • 2.  RE: Basic-UDI-DI

    Posted 18-Nov-2019 10:38
    It depends on which UDI issuing agency you have selected.
    For GS1:  https://www.gs1.org/sites/default/files/docs/idkeys/gs1_gmn_executive_summary.pdf
    For HIBCC:  https://www.hibcc.org/european-union-udi-requirements/
    For IFA:  https://www.ifaffm.de/mandanten/1/documents/04_ifa_coding_system/IFA-Info_Spec_UDI_Code_EN.pdf

    ------------------------------
    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
    ------------------------------

    Original Message


  • 3.  RE: Basic-UDI-DI

    Posted 18-Nov-2019 13:01

    The EU there are four issuing entities:
    GS1 AISBL
    Health Industry Business Communications Council (HIBCC)
    ICCBBA
    Informationsstelle für Arzneispezialitäten - IFA GmbH

    Each one has a standard for the Basic UDI-DI. I've seen the standard for two of them.

    GS1 calls it the Global Model Number:
    The first segment is the GS1 Company Prefix
    The second segment is the Model Reference
    It must 30 or fewer characters

    HIBC doesn't have a specific name:
    The first segment is the Issuing Agency Code (0 to 3 alphanumeric)
    The second segment is the Labeler Issuer Code (1 alpha + 3 alphanumeric)
    The third segment is the Basic UDI-DI Device Number (1 to 20 alphanumeric or special characters)



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    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


  • 4.  RE: Basic-UDI-DI

    Posted 18-Nov-2019 13:25
    GS1 has a newer document that says the Global Model Number must be 30 characters or fewer.

    However, it says that the Basic UDI-DI must be 25 characters or fewer.


    ------------------------------
    Dan O'Leary CQA, CQE
    Swanzey NH
    United States
    ------------------------------

    Original Message


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