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UDI Labeling of Convenience Kits
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UDI Labeling of Convenience Kits
UDI Labeling of Convenience Kits
UDI Labeling of Convenience Kits
UDI Labeling of Convenience Kits
UDI Labeling of Convenience Kits
UDI Labeling of Convenience Kits
UDI Labeling of Convenience Kits
UDI Labeling of Convenience Kits
UDI Labeling of Convenience Kits
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Some Related Topic Tags
convenience kits (medical device), unique device identification (udi)
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  Post Number #1  
Old 13th February 2018, 10:39 AM
tsteele

 
 
Total Posts: 1
Please Help! UDI Labeling of Convenience Kits

At our facility we sometimes compile convenience kits by cannibalizing other products or combining other products before shipping to the customer by combining pouches in a box. Obviously these other products have their own UDI on the pouch level. Since various pouches are compiled and placed into one box (the box being the top level convenience kit with it's own UDI starting with 00), is it necessary to relabel the pouch level (i.e. remove the UDI altogether)?

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  Post Number #2  
Old 13th February 2018, 11:55 AM
miken99

 
 
Total Posts: 22
Re: UDI Labeling of Convenience Kits

The answer is a bit more complicated than a simple yes/no. It depends.

https://www.fda.gov/downloads/medica.../ucm479242.pdf

FDA NIH or EUMED may have more info to clarify the position.
Thanks to miken99 for your informative Post and/or Attachment!
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