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Request For Information: Multiple FDA Device Codes (Procodes) For A Combination Product (Doc ID 2658268.1)

Last updated on APRIL 17, 2020

Applies to:

Oracle Argus Safety - Version 8.2.1 and later
Information in this document applies to any platform.


Currently in Argus and for FDA reporting there is only one entry for the device code at the product level.
Does Argus Safety offer any recommendation for entering multiple FDA device codes (Procodes) for a combination product that for example is a kit and could have 3 procodes (one for the device, syringe and pump)?


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