Thanks Monoj.
My concern is that there would be multiple DIs for what is essentially the same product. Of course with different GTINs.
Hi Fialor,
Somehow I missed to reply to your question, sorry for that.
I assume by saying "Multiple DIs for the same product" you mean that both the parties (the "manufactured by" and "manufactured for") are assigning DIs on their own and registering in the GUDID database for the same product they are dealing with! If that so, then I am afraid this is not necessary and at some point this is wrong. Only one party (who falls under the FDA's definition of "labeler") has to take the responsibility and the other party shall refrain from registering the same product in the database. In your case if the company ("Manufactured By") is the "labeler" and selling the same product to different distributors (including your client) then, to make things simple, they should provide their own DIs on the labels as well as to the database unless,
1. there is no change in the "Brand Name" for different distributors
2. there is no change in the "Version or Model" for different distributors
3. there is no change in the "device count" for different distributors at any given packaging level (except the shipping containers or the pallets)
The above three points are the basic elements, from distribution perspective, which trigger "New DIs" for the product on their labels. You can check this list from FDA (attached file). So, if your client is responsible to make significant changes with the device in order to modify the labeling (except adding their company name and address which is not considered as the significant change) which trigger new DI then, of course, your client shall generate new DIs and assign it on the labels as well as provide to the GUDID database. In that case, "YES" there will be different "DIs" for literally the same product but now this is acceptable as it falls under the above "New DI Trigger" concept.
On the other hand, by saying "Multiple DIs for the same product" if you mean that different DIs at different packaging level then I would say that this is normal and this is the basic idea behind implementation of the DIs.
there would be multiple DIs for what is essentially the same product. Of course with different GTINs.
By the way, "DI" and "GTIN" are the same thing, except "DI" is the official term from the FDA whereas GTIN is the official term from the GS1.