GUDID - Packaging Levels

ASteel

Starting to get Involved
The company that I work for is beginning to input data into the GUDID and we have hit a snag with regards to the Package DI section.

We have three levels of packaging:
Unit of Use (pouch) = 100
Secondary Pkg (carton) = 200 (carton of 6 - 100s)
Tertiary Pkg (case/shipper) = 300 (case/shipper of 4 - 200s)

My question is for the carton (200) and case (300) configurations. If the following is true, what would be the Package DI Number, Quantity per Package, and Contains DI Package? I have reviewed the Data Elements Table and the system will not let me enter data from how the examples in the elements table read.

Primary DI Number for 200 (carton) = 12345
Primary DI Number for 300 (case) = 12350
Unit of Use DI Number (pouch) = 12340
 

ASteel

Starting to get Involved
Anyone else have expertise entering data into GUDID that contain multiple levels of packaging?
 
Is your shipper going to be sitting on an inventory shelf as is? Do you have another shipper that allows various quantities? Why does the shipper have to be traceable? Is it possible to instead keep traceability on the cartons?
 

ASteel

Starting to get Involved
The shipper most likely will not sit on a shelf for very long if at all. We only use one size shipper and the quantity does not vary for that product line.
I received assistance from the FDA help desk and we walked through the issue I was having.
Thank you for your help!
 

monoj mon

Trusted Information Resource
I received assistance from the FDA help desk and we walked through the issue I was having.
Since other members of this forum may also face similar situation, it would be great if you could briefly (if not elaborately) explain what is the measure that you have taken after consulting with the FDA.
 

ASteel

Starting to get Involved
Since other members of this forum may also face similar situation, it would be great if you could briefly (if not elaborately) explain what is the measure that you have taken after consulting with the FDA.

Of course! If you have multiple levels of packaging, such as this:

Unit of Use (pouch) = 100
Secondary Pkg (carton) = 200 (carton of 6 - 100s)
Tertiary Pkg (case) = 300 (case of 4 - 200s)

You only need to create one page in the GUDID. The main entry would be your Unit of Use packaging (e.g., 100), which would be a device count of 1. When you reach the Package DI section, this is where you will enter the DI #s for the secondary and tertiary levels of packaging.

My mistake was that I completed a draft page in the GUDID for every level of packaging, so I had to delete the secondary and tertiary pages and add that information to the unit of use pages for all of our products.
 

monoj mon

Trusted Information Resource
The main entry would be your Unit of Use packaging (e.g., 100), which would be a device count of 1.
What I see here is that you have (probably) misunderstood the concept of "Unit of Use". If it is in "Pouch" configuration and if the device count is "1", then it is not considered as "Unit of Use". The DI you are referring here (as unit of use packaging) is actually the "Primary DI Number" applied on the lowest level of packaging. See the definition of UoU from the FDA;

1600392625306.png

The UoU DI does not appear on the device label, and you don't create the page to input the UoU DI. What you input is the Primary DI which appears on the lowest level of your packaging (in your case, I guess it is the pouch that you are talking about).

Primary DI Number for 200 (carton) = 12345
Primary DI Number for 300 (case) = 12350
Then comes these. These are not your Primary DI numbers, they are in fact your "Package DI" numbers which you would need to include in the lower section of that GUDID page that you created for your "Primary DI".

Unit of Use (pouch) = 100
Secondary Pkg (carton) = 200 (carton of 6 - 100s)
Tertiary Pkg (case/shipper) = 300 (case/shipper of 4 - 200s)
Another confusion is this. What I understood now (please correct me if I am wrong) is that
1) You have a device packaged in a Pouch (say it has a DI 100)
2) You pack the pouch in a paper box (say it has DI 200 and it contains 6 of 100)
3) You then pack the paper box in a carton (say it has DI 300 and it contains 4 of 200)
The confusion here (I assume) you may have is in the definition of the packaging. When you say "shipper" people usually guess that you are talking about that big "shipping containers" which the shipping companies use to ship your product to its destination. This is not what (again, I assume) you are referring to here,
Yes, that is correct; however, we chose to place a UDI on the shipper as it is also a configuration available for purchase and subject to traceability.
What I understood, above you are referring to the "Shipping Carton" which is your final level of packaging and you have done your "Shipping simulation" to conduct your "packaging validation" testing with that.

See this below image (copied from this link).

1600396496645.png

So, if we consider the above hypothetical example and enter the data into GUDID then it would look something like this. (The below picture is hypothetical that I created using power-point to post in this forum.)

1600396794847.png

Here, one pair of Surgical gloves (where we don't put any UDI or label) is the "Unit of Use"; whereas the paper box which contain "100 pairs of Surgical gloves" is the lowest level of packaging and it contains the "Primary DI". Subsequently, the blue paper box (DI 201) contains 4 white paper box (DI 101). And the "Shipping Carton" (DI 301) contains 5 of blue paper boxes. Any packaging (e.g. shipping container) beyond this level of packaging does not contain the UDI and so does not come under traceability.
 
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