UDI Questions on Control Units

ChrisW

Starting to get Involved
#1
Hello, I have several UDI questions that I can't seem to get a strait answer on anywhere.
1. We are designing a reusable control unit to power a single use catheter. The control unit, a power cord and IFU would be shipped together. Does the shipping box that would also have the IFU and power cord also need to have the UDI on the box or is the UDI information on the control unit enough?
2. If we ship the exact same control unit just with a different IFU and power cord for Europe would this be considered a configurable system and be able to have the same UDI.
3. If the same shipping box that was used to ship control unit, power cord and IFU would also fit cables could those be sent in the shipper box when needed. It would not be sold as a kit, each part would be ordered independently and have their own UDI.
4. There is a cart that is a component of this unit but that is also shipped separately. No UDI because its a component.

Not sure if it matters but the cables are reusable and can only be used with this control unit but can be replaced if needed.

Thank you
 
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yodon

Staff member
Super Moderator
#3
Does no one have any in-depth UDI experience? Thank you for any input.
That's probably not inaccurate!

It's tough finding any guidance, much less on particulars like this.

My understanding is that shipping packages ("logistics units") do not need a UDI (see GS1 FDA FAQ). Do note that other layers of packaging, though, do require UDI.

#2 sounds reasonable but I don't have any references to base that on.

I don't know about #3. I was thinking that replaceable parts require UDIs. Maybe not.

I think you're right on #4 with the component logic.

Don't bank on these replies. It's all still pretty fuzzy for me.
 

monoj mon

Quite Involved in Discussions
#4
Sorry, somehow I missed both of your posts.
1. We are designing a reusable control unit to power a single use catheter. The control unit, a power cord and IFU would be shipped together. Does the shipping box that would also have the IFU and power cord also need to have the UDI on the box or is the UDI information on the control unit enough?
According to US FDA, each level of packaging (other than the shipping containers) requires UDI. In my understanding, your shipping box/carton will be considered as packaging and will need to have a UDI.
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2. If we ship the exact same control unit just with a different IFU and power cord for Europe would this be considered a configurable system and be able to have the same UDI.
At least this is what our issuing agency has conveyed to us, we can use the same UDI for both US and Europe provided the packaging level and content are identical.
3. If the same shipping box that was used to ship control unit, power cord and IFU would also fit cables could those be sent in the shipper box when needed. It would not be sold as a kit, each part would be ordered independently and have their own UDI.
The main idea of assigning UDI to each level of packaging is to identify what's inside and what are the information provided for each of them. If you use the same UDI for boxes with and without cables, I am afraid, that might cause some complications. For such packaging configuration, I would suggest to have a separate UDI for both of the instances (with and without cables) and mention it in the GUDID database. By doing so you would avoid any future complication.
4. There is a cart that is a component of this unit but that is also shipped separately. No UDI because its a component.
Cannot comment on this.
 
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yodon

Staff member
Super Moderator
#5
According to US FDA, each level of packaging (other than the shipping containers) requires UDI. In my understanding, your shipping box/carton will be considered as packaging and will need to have a UDI.
Not following... if ti's a shipping container, why then, would it need a UDI?
 

ChrisW

Starting to get Involved
#7
Thanks for you input. We do need a different UDI between US and EU because we pack with a different power cord.
 
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