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.
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.
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