Barcodes and UDI FAQs • UDI rule requires that whatever PI(s) appear on the device label or package (for whatever reason) must also be included in the UDI. • UDI should be on every level of packaging, except for the logistics unit. • For Class 1 devices U.P.C. number will serve as the UDI – which must still be registered in the GUDID with the required data attributes (no PI is required on the label) • FDA requires UDI info in both AIDC (auto-id) and human readable forms on product label • Types of acceptable barcodes determined by GTIN issuing agency, e.g. GS1 • Can be either 1D or 2D barcodes, or an RFID tag • DI must come first in data stream, followed by PI data