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별칭: Unique Device Identification

Unique Device Identification, the FDA system requiring barcodes on medical devices for tracking.

관련 용어

GS1 DataMatrix NDC

…Outer shipping cases : ITF-14 or GS1-128 Healthcare (FDA UDI) : GS1 DataMatrix or GS1-128 Automotive : Code 39 (AIAG…

…is required by the FDA for Unique Device Identification (UDI) on medical devices and by DSCSA for pharmaceutical…

Healthcare GS1 Standards: GTIN, AIDC & UDI Compliance Healthcare is one of the most barcode-intensive…

FDA UDI Requirements: A Barcode Compliance Guide The FDA's Unique…

…for medical devices sold in the EU market, including a UDI system similar to but distinct from the US FDA's approach.…

…and returned to tray inventory Regulatory Context FDA UDI requires direct marking on reusable Class III devices EU…

…implants, from hip joints to cardiac pacemakers, carry UDI barcodes on their packaging that enable lifetime…

…Data structure Primary + Secondary Application Identifiers UDI accredited Yes (FDA and EU) Yes (FDA and EU) Industry…