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
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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