Labelling reconditioned medical device

evan_kim90

Involved In Discussions
Hi,

I have question regarding for reconditioned medical device.
So, our company planning to re-using some parts( non-skin contact parts.) and re-sending to customer as 30 days trial device.
My question is, if we do recondition medical devices, do we need a new label with a new UDI?
Or we can use same UDI, for original new medical device one?
The contents are exactly same.
 

yodon

Leader
Super Moderator
When you say "reusing some parts" are you saying you are collecting units that have already been distributed and used in the field then refurbishing them or are you scavenging parts from those devices to be used on other devices? Or something else?

Why is it a 30-day "trial"? Are you prohibiting use on humans?

Maybe more basic: is your company the original legal manufacturer?

What do you include in the UDI-PI portion?
 

evan_kim90

Involved In Discussions
When you say "reusing some parts" are you saying you are collecting units that have already been distributed and used in the field then refurbishing them or are you scavenging parts from those devices to be used on other devices? Or something else?

Why is it a 30-day "trial"? Are you prohibiting use on humans?

Maybe more basic: is your company the original legal manufacturer?

What do you include in the UDI-PI portion?
Hi, Sorry for less information. It is for human medical device.
So we send our device as a 30 days trial and if customer like it they can keep it and otherwise they can ship back to us.
So we want to refurbish this came back device. We are re-using electronic parts and change skin contact parts.
For UDI-PI, If I understand correctly, we put project + Item.
 
Top Bottom