As a global medical device manufacturer, MicroVention is required to comply with the United States' FDA's Unique Device Identification (UDI) labeling requirements. Watch our video series to see how they easily created the GS1 barcodes needed for UDI labels using CODESOFT's GS1 barcode creation wizard.
MicroVention, a global medical device manufacturer, had outgrown its manual label creation process and turned to TEKLYNX to implement a centralized label management system. They had the added complexity of complying with the United States FDA's unique device identification or UDI labeling requirements.
Frank Carranza: Initially when we did this implementation we were under the deadline of having to implement the UDI requirement that is mandated by the FDA. And the software, CODESOFT, helped us build all those barcodes that were necessary for every single product that's distributed here in the United States. The one key component that helps in the UDI process was the UDI barcode wizard that's in the software. That's how I created all the different UDI compliant barcodes for our labels. And it's saved a tremendous amount of time.
Bob Lenski: What TEKLYNX does really well is that they take the requirements out in the industry and they simplify it. And that's really where the wizards built into the CODESOFT solution are able to take a complicated workflow or a complicated situation and make it easy. And that's really the purpose of our wizards in our application and they're really good at doing it. Now specifically with the GS1 wizard and when we used it for MicroVention, it makes sure that you're using the right application identifier when you're creating a barcode and that those application identifiers are being paired appropriately. At a high level, if you're gonna use application identifier 01 which is the GTIN you're gonna need to pair that with application identifier 10 which is the lot number and then maybe 15 which is the expiration date. Our application goes the extra mile and making sure that you're getting those pairings correct and that the information you're typing in is also correct.
Frank: The ease of making those barcodes UDI compliant in the software helped us a lot. It was very easy to to put them on the templates and get them through.
Thanks to the GS1 wizard in CODESOFT, MicroVention was able to achieve UDI compliance. To learn more about how TEKLYNX can help you meet labeling regulations, get in touch through our website or give us a call. And stay tuned for the next episode!
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