Tag: Unique Device Identification

29
Nov

UDI Examples of Medical Devices Under a Voluntary Device Correction

UDI Examples – Compliant or Non-Compliant? CONMED Corporation Issues a Voluntary Device Correction for PadPro and R2 Multi-function Defibrillation Electrodes. The labels of which are examples of UDI implementation by the CONMED Corporation. View more UDI labels of these products here. Compliance Issue The following UDI example is based on the GS1 system of standards.  As for the date format, UDI labels

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29
Nov

FDA Unique Device Identification FDA UDI GS1 Standards

FDA UDI FDA UDI Quick Reference Guide to GS1 Identifiers & Barcodes FDA UDI: Device Identifier (DI) and Production Identifier (PI) UDI: GS1 GTIN or GTIN + GS1 Application Identifier (AI) GTIN*: Global Trade Item Number Download Quick Reference Guide to GS1 Identifiers & Barcodes here. Last Updated: 2015-11-27

6
Oct

FDA Unique Device Identification UDI Application Examples

By Dr. David Lim, Ph.D., RAC, ASQ-CQA (LinkedIn) FDA Unique Device Identification (UDI) Final Rule and GUDID Guidance FDA UDI Information UDI Rule and GUDID Guidance at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#ruleguidance Benefits of Unique Device Identification at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#benefits Compliance Dates for UDI Requirements at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#compliancedates Accredited Issuing Agencies at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm#agencies On September 24, 2013, the Food and Drug Administration (FDA) has released a final rule (download it below)

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22
Sep

LIVE Online Seminar Implementing Unique Device Identification Systems

18
Jul

LIVE Seminar for FDA UDI Overview

FDA UDI Final Rule Last Updated: 2015-12-29