Does your hook-up kit label look like this? 
↓ 


(Pictured: Sample hook-up kit label with proper UDI representation). 

 

Is your Kit Supplier FDA/UDI compliant?

FDA Registered?
All hook-up kit manufacturers must be registered with the FDA as a Re-Packager/Re-Labeler.  This means we follow FDA regulation by following Good Manufacturing Practices to insure safety and effectiveness of medical devices.


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.  

Benefits of Using Danlee:

        - FDA registered and UDI compliant - 
        - Private labeling capabilities - 
        - Fast & efficient delivery - 
        - High quality products - 
        - We can kit anything. Disaster Relief Kits, Personal Hygiene Kits, MRSA kits and much more.
        - Danlee is also known for our product conversion. Need high volumes of items folded, labeled, packed, cleaned? We can help.
        
Give us the opportunity to help.


Call us at 1.800.433.7797 or e-mail us at [email protected] for more information.