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  • 1.  GTIN Barcode

    This message was posted by a user wishing to remain anonymous
    Posted 22-Jun-2020 08:35
    This message was posted by a user wishing to remain anonymous

    Is a GTIN Barcode for a medical device needed on the outside of a box being shipped to the US from Asia?

    If so, is their a requirements for its position on the outside of the box?

    Thank You


  • 2.  RE: GTIN Barcode

    Posted 23-Jun-2020 04:29
    Hello Anon,

    Just keep in mind the GTIN barcode may be different, may be the same, or just a portion of Unique Device Identification (UDI) so make to not get these confused.  GTIN can be used for any product around the world, but there are specific requirements for UDI in various countries and more being developed.  To answer your question, it really depends on the country and any importation requirements.  This may not also apply to just shipping box for importation requirements, as there may also be requirements for GTIN barcode (number) on different levels of packaging for distributor and end-customer use.  For any type of barcoding (GTIN) you need to understand the entire sales and distribution process for your product once it leaves your dock and finally makes it down to point-of-use.  There is more detail needed to answer your question which much of it would need to be understood from your distribution network.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: GTIN Barcode

    Posted 23-Jun-2020 19:42

    That would depend.

    If you are shipping a variety of items to an end user which is dependent on their order, no GTIN is required for such a shipping case per FDA UDI Rule. Instead you would include a packing slip or other transportation documentation regarding contents of the shipment.

    GTINs are Global trade Item Numbers should be assigned to each fixed packaging level intended to be sent to another company.
    To fulfill the spirit of the preamble to the FDA UDI Rule, you would want to have the UDI-DI+PI on every level of packaging so that the item can be traced to the point of use.
    GTINs are typically assigned up to the highest shipping quantity that can be ordered by a customer which can vary; case, gaylord or pallet level.
    Regarding placmeent of the GTIN carrier, GS1 US has a number of documents available free in their resource library. 
    From Guidelines for Bar Code Symbol Placement Revised May 2007 (c) GS1 US
    7.1
    General Rule
    The bar codes on units intended for general distribution should be upright (in picket fence orientation) and placed on the sides of the unit.  Each item should have at least one bar code and two are recommended when these are preprinted.

    7.1.2 Symbol Placement on Cartons and Outer Cases
    For cartons and outer cases, symbol placement will vary slightly in practice, however the target placement for the bottom of the bar code symbol is 32 mm (1.25 inches) from the natural base of the item.  The symbol including its quiet Zones should be at least 19 mm (0.75 inches) from any vertical edge to avoid damage. 



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    Stacey Henning
    Principal Specialist, Regulatory Affairs
    Waukegan, IL United States
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    Original Message


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