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UDI-PI on a package that contains more devices

med_cert

Involved In Discussions
#1
In IMDRF UDI WG's "Unique Device Identification system (UDI system) Application Guide" from 21 March 2019, the folowing example is presented

Example 2: A manufacturer manufactures two versions/models
of a device. Model A is more popular than Model B. To sell
more of Model B, the two models, when sent to retailers and
distributors, are packaged in an assorted case that always
includes 5 of Model A and 3 of Model B, i.e. a standard configuration.
Although both devices may have similar indications for use,
Model A and Model B were not combined in a device package
with the intent they are used together to achieve a common
intended use. Rather, these two or more different
models/versions of devices were packaged together for business reasons.
This package configuration itself is neither a device nor a kit but a shipping configuration.
However, to adequately identify this fixed configuration through distribution and use, packages require UDI.
Recommended best practice is to place a UDI on each device in the packaging configuration and
place a UDI on the package that contains the devices.

Question:
What UDI-PI should be placed on UDI of this package (if each of those two devices have their seperate UDI-PI...)?
 
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pziemlewicz

Involved In Discussions
#2
DI as the unique identifier for that package configuration
PI as the date on which it was packed, which leads you back to the original manufacturing lot #s for each part.
 

med_cert

Involved In Discussions
#3
Thanks, that was also my assumption... however, I don't see any benefit... each part already has tracks to the original manufacturing... I really don't see the reason why this PI should be important (I hope it has some deeper purpuse not only because it's written so... :) )
 
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