FAQs: Hook-up Kit Production, FDA Registration & UDI Compliance


Does your hook-up kit label look like this? 
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(Pictured: Sample hook-up kit label with proper UDI representation). 

 

What is UDI?  
The US Food and Drug Administration (FDA) has established a unique device identification system to adequately identify medical devices through their distribution and use. As a result of this implementation, most medical devices must bear a unique device identifier (UDI) on their label that is printed both in alphanumeric and machine readable forms (barcode). Patient Holter and event recording kits (hook-up kits) are classified as convenience kits by FDA standards and are subject to UDI medical device regulation.  

Worried About The Deadline?  
All convenience kit users/manufacturers (labelers) are mandated by September 24, 2018 to comply with these new rules; meaning all kit labels after this date must bear a UDI. Those that do not comply with these new rules are subject to consequences defined by the FDA. 

How We Can Help!   
Are your products UDI compliant? Danlee can take the headache and stress of UDI compliance off your 2018 to do list. We currently produce over 450 different variations of hook-up kits. We’ve been FDA/UDI compliant since August of 2016. This is our business. This is what we do.

Benefits of Using Danlee:
  ● FDA registered and UDI compliant - check! 
  ● Private labeling capabilities - check!
  ● Fast & efficient delivery - check! 
  ● High quality products - check!

Give us the opportunity to help.

Want to know more about UDI compliance? Check out the video below. 




Looking for this information to print or e-mail? Click here for a digital info sheet

Want to check out some of our kits? Visit the kits section of our website by clicking here

Call us at 1.800.433.7797 or e-mail us at info@danleemedical.com for more information.