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.

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. 

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.

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!

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

Challenge
Astute Medical manufactures biomarkers that are used to identify high-risk, acute medical conditions in critically ill patients. The Federal Drug Administration (FDA) issued a mandate that medical devices must carry a Unique Device Identifier (UDI), which requires a greater volume of information than had been previously required.

Astute Medical sought a compliance labeling solution that would meet UDI requirements in accordance with GS1 Standards. The manufacturer also wanted to receive accurate and repeatable verification results and a solution that included a Validation Protocol to document compliance with these requirements. We needed to not only comply with federal regulations, but also ensure that we were sending out our medical devices with a high-quality barcode, “to avoid returns,” explained Susan Shelton, Materials Management and Procurement Manager of Astute Medical.

Analysis

Astute Medical designs, engineers, and manufactures novel biomarkers that enable clinicians to identify acute conditions in their critically ill patients before the symptoms become evident. Products like the NephroCheck Test and Astute140 Meter fall under the guidelines of the FDA’s Unique Device Identification rule. This system was established to identify medical devices throughout their distribution and use, providing critical traceability that benefits the patient, caregiver, manufacturer, and distributor.

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