GUDID Packaging - Two part package

[Pmarszal]

Our company is in the process of creating GUDID submissions to an "unpublished" state and had a questions about a packaging.
We currently have a individual "part" that is also packaged into a "part" pack of 2. The 2-pack in our system is assigned a different catalog number then the individual part.

My initial though was to create the 2-pack as a "Package DI" but am second questioning if this is the correct way to assign this. I have also tried to assign the "device count" of 2 and insert the unit of use "DI number" (of the individual part) to the record but record review notes that I cannot use an already used DI number for this.

Your help would be greatly appreciated and am thanking you in advance for reviewing my technical question.

 

[QA-Man]

Re: GUDID: Packaging Question

Don't use the unit of use DI in GUDID (I'm assuming you're using web interface)

Enter the unit of use in the primary DI and then make the device count 1. You'll see unit of use is then "greyed out". The primary DI will the act as your unit of use.

You can then add whatever packaging DI's you want, including those that contain only one 1 of the primary DI.

 

[Pmarszal]

Re: GUDID: Packaging Question

Thanks QA-Man!


So just to verify your recommendation: Im using Web User Interface.
Create a DI record for the base package of a single pin (qty.1) which has a catalog number.
Add the Package DI for the qty of 2, even though the Package DI has its own catalog number in our system and will be labeled with that catalog number?

Again, I am appreciative of all recommendations as we are down to crunch time soon

 

[QA-Man]

Re: Question on GUDID

If you're worried about identifying the catalog number, you can put it under the Package Type field.

I had a similar situation where two different catalog numbers were using the same unit of use. I put "Box (XXXX)" and "Box (YYYY)", where XXXX or YYYY is the catalog number, in the Package Type field.

 

[Pmarszal]

Re: Question on GUDID

QA Man!

I appreciate all your help and will take your advice and create it as a Package ID.

Another question you might be familiar with:
Our single use device contains MDD symbols on labels and these are then packaged into a box of 5 to ship to customer/hospital etc. UDI and GUDID guidance specifies that all non-variable information needs to be on the 5-pack label and am guessing this is implying UDI information ONLY and not symbols and all other information that is on the single label.

You have provided great advice to our company as I have tried contacting the FDA Help Desk with these questions but am sure they are loaded with questions before the deadline and haven't received a response.

Thanks!

 

[QA-Man]

Single-use devices don't necessarily need a UDI on the immediate packaging. 21CFR801.30(a)(3) states:

Individual single-use devices, all of a single version or model, that are distributed together in a single device package, intended to be stored in that device package until removed for use, and which are not intended for individual commercial distribution. This exception is not available for any implantable device. The device package containing these individual devices is not excepted from the requirement of 801.20, and must bear a UDI.

I assume MDD is Medical Device Directive It depends upon the symbols and purpose of outer packaging. If it is a CE mark, then I would put it on all packaging levels. If its the "do not use if package is damaged" symbol (ISO 15223-1 5.2.8/ISO 7000 Reg. No 2606), maybe that should just go on the immediate packaging.

The FDA released a final rule on the use of symbol in June here (you may already be aware of this).