What is a Medical Unique Device Identifier (UDI) ?

Learn how GS1 Standards can help your company

The U.S. FDA Unique Device Identification (UDI) Rule* establishes a unique device identification system for medical devices. Under the rule, medical devices will be marked with a Unique Device Identifier (UDI) that will appear on the label and package of a device. UDIs will be presented on device labels in both a human-readable format and a machine-readable format (e.g., a barcode).

GS1 Standards can be used to support your UDI implementation for all Classes of medical devices.

GS1 Standards for U.S. FDA UDI Certificate Course

Avoid common mistakes and receive guidance with the GS1 Standards for the U.S. FDA UDI Online Certificate Course

BD Advances Patient Safety Through Precise Identification​

Becton, Dickinson and Company, also known as BD, is one of the largest global medical technology companies in the world. With the help of GS1 Standards, they have been able to identify billions of medical devices at each point in the supply chain all the way to the patient.

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implementation guideline

Implementation Guideline

Learn how to implement GS1 Standards to meet certain aspects of the U.S. FDA UDI Rule.

quick start guide

Quick Start Guide

Designed for Medical Device Labelers implementing U.S. FDA UDI requirements

quick start guide

Standards Guidance

Assigning Device Identifiers using Global Trade Item Numbers

implementation support

Implementation Support

Customized support to help improve operations and enhance quality of care

Resources for Healthcare Providers

Are you a Healthcare Provider and looking for education and implementation resources? If so, please visit www.gs1us.org/HealthcareProviders to learn how GS1 Standards can help your organization modernize its supply chain, improve patient safety, and reduce costs.

*For information about the rule, see the U.S. FDA Unique Device Identification System

Disclaimer: GS1 US is the local GS1 Member Organization that supports implementation of the GS1 System in the United States. GS1 US employees are not representatives or agents of the U.S. FDA, and the content herein has not been reviewed, approved, or authorized by the U.S. FDA.

GS1 is a U.S. FDA-Accredited Issuing Agency for UDI, and GS1 Standards are authorized for use in implementing the requirements of the U.S. FDA UDI Rule.