UDI for two units with different S/N on the same package/case

#1
Hi Everyone,

We manufacture a Class II Medical device and needs to include the serial number on the UDI.

How should we do the UDI for 2 Units with different Serial numbers on the same package/case?
Can we have 2 UDI labels that contain different serial numbers for that package?
Please see attached samples UDI Package Label sample.jpg UDI Device Label sample.jpg

I have tried to ask FDA Helpdesk but they just quote the rule and don't give a direct answer to this question.
 
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monoj mon

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#3
As mentioned in this FDA Document, PI is 'conditional' (i.e. not 'mandatory).
1628735236666.png
So, based on this I would suggest you the following;

  1. Assign a package DI (say DI 98765432100000) for the package which contain two of your devices.
  2. You already have a primary DI (say 12345678900000) for both of your devices inside that package.
  3. Register your primary DI at the GUDID database and set the device count to 1. At the Package DI section, insert your newly created Package DI and set the device count 2 containing the Primary DI.
  4. In the PI Identifier flags section, indicate which PI attributes are supplied with the Primary DI.
  5. On your actual outer packaging, place a newly created label containing only the 'Package DI' while inside the package place the already existing labels which contain the 'Primary DI' along with the PI Attributes.
 
#4
Welcome kevin14!

Are there two separate devices in the package? One image looks like it is an instruction booklet.
Yes, there will be two of the same device with different serial numbers in the package. We will put the UDI on the IFU booklet because we do not need to have it mark on the Unit as our unit doesn't need to undergo high-level disinfection/sterilization before each use.
 
#5
As mentioned in this, PI is 'conditional' (i.e. not 'mandatory).
View attachment 28071
So, based on this I would suggest you the following;

  1. Assign a package DI (say DI 98765432100000) for the package which contain two of your devices.
  2. You already have a primary DI (say 12345678900000) for both of your devices inside that package.
  3. Register your primary DI at the GUDID database and set the device count to 1. At the Package DI section, insert your newly created Package DI and set the device count 2 containing the Primary DI.
  4. In the PI Identifier flags section, indicate which PI attributes are supplied with the Primary DI.
  5. On your actual outer packaging, place a newly created label containing only the 'Package DI' while inside the package place the already existing labels which contain the 'Primary DI' along with the PI Attributes.
We are already doing steps 1-3 on what you have suggested but from what we understand we also need to include the PI Attributes on Package UDI because we have the serial number on our label, this is the reason we are confused as it doesn't make sense to me to have the PI on the package UDI.
 

monoj mon

Quite Involved in Discussions
#6
we also need to include the PI Attributes on Package UDI because we have the serial number on our label,
In my opinion, that's not the case. Your UDI information contains exactly what's on that particular label, don't bother what's on another label at a different level. If your package DI doesn't contain a serial number then why would you put it in your UDI! Serial numbers are for your Primary DIs, as your device labels contain serial numbers. If your package DI contains any PI attribute then, yes, include it in your UDI. But, including the Serial Number as a PI attribute on the higher level labeling doesn't make sense to me.
 
#7
In my opinion, that's not the case. Your UDI information contains exactly what's on that particular label, don't bother what's on another label at a different level. If your package DI doesn't contain a serial number then why would you put it in your UDI! Serial numbers are for your Primary DIs, as your device labels contain serial numbers. If your package DI contains any PI attribute then, yes, include it in your UDI. But, including the Serial Number as a PI attribute on the higher level labeling doesn't make sense to me.

Hi, Thank you for your reply.

We also put a sticker serial number on the package for identification.
 
#9
I have had trouble finding official advice for this exact situation. What I did find was:
  • - an older Cove thread
  • - from BSI
I hope this helps.
Thank you Jen and monoj,

I will present my findings to the management and see if we should:
  1. Have just the DI on the package label or
  2. Have 2 UDI (DI+PI) to reflect the different serial numbers.
I just also talked to one of our consultants and he suggested to just do it the way we understand the rule as there is no official advice on how to do it. Basically, just fix it if it was found non-conforming on our MDSAP audit hoping that they have a better suggestion on how to present the UDI for two units with different serial number on the same package.

Our Stage 1 will happen this September and Stage 2 on October, I will try to reply back to this forum if I find the best way to do this.

Again thank you so much for your supports
 
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