What is a UDI, the Unique Device Identifier?

Posted January 8, 2019

What is a UDI, the Unique Device Identifer? 

The FDA has established and implemented a unique device identification system that is used to adequately to identify medical devices through their distribution and use. With these unique device identifers implemented, it will be able to trace and track medical devices, improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.

Currently, Class I,II,III medical devices distributed in the United States must carry a UDI to meet the requirements of the Food and Drug Administration(FDA). No UDI? No Business! Medical device products identification labels help maintain compliance, ensure brand consistency, improve operational efficiency, and support business growth.

Check out the infographic and call us today to see how Barcodes and Zebra can help you at every stage of the route to become UDI compliant.

udi-journey-infographic

 

Currently, enjoy free 2-day shipping on all orders of $250+ made online at Barcodesinc.com through January 9,2019. Exclusions apply.

Enjoy free 2-day shipping on all orders of $250+ made online only at Barcodesinc.com through January 9, 2019 at 11:59 pm CST. Offer cannot be combined with other promotions or discounts. Offer valid on web pricing only. Offer valid in the US only. This offer is not valid on international orders. Certain product exclusions apply on supplies (ribbons/labels) and cash drawers. 

The Guide to Succeeding with UDI Compliance

Posted April 5, 2018

To go along with yesterday’s blog about Unique Device Identification Compliance some may be wondering what is required to be fully compliant with the FDA. With another UDI deadline approaching it’s important to know the steps that will help you get in compliance. With the help of Zebra Technologies, they wrote a small walk through to help you through each step.

Read the walk through below to clear up any confusion. If you have any further questions please don’t hesitate to contact our dedicated account managers.

Unique Device Identification Compliance

Posted April 4, 2018

The Food and Drug Administration (FDA) has established and continues to implement a unique device identification system to properly identify medical devices through their distribution and use. Once fully implemented, the label of most devices will include a unique device identifier (UDI) in human and machine-readable form.

The unique device identification system will be phased in over the next couple of years and offers several benefits. Implementing UDI will improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation. To learn more about UDI read the infographic below!

UDI-Info-1
UDI-info-2

 

If you want to learn more, feel free to contact our dedicated account manager.