UDI Label Case Study

A long-term medical device customer needed to transition the labeling on products to new UDI labels that met specific FDA requirements. The deadline for the transition was quickly approaching so they reached out to JN White® to help them develop and execute the transition to the new labels in a timeline manner. JN White investigated the requirements, tested current labels and determined what alterations needed to be made to meet the requirements. In addition, the team at JN White managed the entire transition and made certain new labels were in place by the deadline.


A major U.S. medical manufacturer and long-time customer contacted JN White with a timely request for their Class II medical device labeling. The criteria included labels that could:

  • Withstand temperature, humidity, chemical testing, and CaviWipe™ cleaning
  • Color match existing housing
  • Be aesthetically appealing
  • Following the FDA label requirements

Additionally, the customer needed barcode grade reports so that they could substantiate adherence to the new policy in the event of an audit. Finally, the project needed to be completed expeditiously as the deadline was quickly approaching.

How JN White® Helped

The team at JN White quickly began evaluating the labels the customer had been using in the past to determine if the current labels would meet UDI requirements as long as the laser-readable barcode could be added. Ultimately, all tested adhesives passed temperature and humidity tests however, the ethanol removed clear varnish and digital ink. The team discovered that top-surface variable printing of contrasting colors with protective over laminate resulted in both the highest barcode functionality as well as surpassed barcode grade requirements. In addition, JN White invested in specific equipment to enable the printing and testing of these types of labels.

The Result

As a result of this project, JN White was able to quickly and painlessly transition the customer from their existing labels to labels that met all the FDA requirements for UDI labels on medical devices. The team became experts on the requirements and guided the customer through the process. The final result was the implementation of Class II UDI medical device labeling across all products produced at JN White. Because of the quick response by JN White to this request, the transition was accomplished within the timeframes required for compliance.

See What Our Customers Are Saying

"Very pleased with your team's response to our need during the COVID-19 crisis."
Lisa L., Medical Device
"JN White has been exceptional in working with our company in order to develop the look and feel of our new MRI patient worn transmitter. We had originally worked with a prior manufacturer for an earlier version of this product with much less desirable results. JN White delivered a clean professional product at a very reasonable price on time!"
Gary P., Medical
"We had very little information to work with and Jessica James made it nearly effortless on our end to get us exactly what we needed in a timely manner."
Lexi W., Industrial Equipment
"Getting any after-market graphic overlays done always has a certain risk factor in getting it all right. You guys were helpful, patient, & knowledgeable to achieve the best end result. Even pointing out some things that might be [an] oversight or [areas for] improvements. The outcome was perfect."
John S., Technology
"The print task was between the USA and Australia and everything went so smooth. I submitted a drawing, got a return email for me to confirm what I wanted. Even though this was over the Christmas period the print was waiting for me when I got back to work after the holidays. Great job and thanks."
Matt C., Military
"All of the folks there at JN White that I have talked to and dealt with have been very nice and professional."
Vern L., Industrial
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Sara H., Medical
"It has been a pleasure working with JN White. We switched suppliers for some of our products to your company and you have given us higher quality. Excellent work!"
Roger W., Education
"I feel confident that JN White will do my order correctly."
Marie P., Government
"I found working with Sara to be a pleasant experience. We were trying to dial in the color to get just the right look on the printed substrate...Sara sent us a sample print sheet that had several variations, up and down, from the colors we specified, which allowed me to pick exactly the color we wanted. The end result product is perfect!"
Don M., Safety
"Our department has used JN White for a number of years for our inspection labels. They always respond very quickly when we contact them to place an order and communication is great with any questions we have. Highly recommend them."
Jim R., Government
"Easy process and great people to work with."
Richard Z., Military
"I'm very satisfied with your service. Always looking forward to bring the best!"
Ramses Z., Medical Devices
"JN White is very responsive to their customers. Product is delivered as expected...and they provide quality products. They have a clear understanding of the obstacles facing US based customers regarding the entire supply chain."
Bob M., Point of Sale
"We always deal with Steve Matacz. He is the best at making sure all details are perfect. Timely communication with any questions we have."
Paul A., Recreational
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RoseMarie C., Utilities
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Sara H., Medical Devices