GUDID - Packaging Levels

ASteel

Starting to get Involved
#1
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
 
Elsmar Forum Sponsor

indubioush

Quite Involved in Discussions
#5
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
#6
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

Involved In Discussions
#7
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
#8
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

Involved In Discussions
#9
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.
 
Thread starter Similar threads Forum Replies Date
J GUDID Labeling and Levels of Packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
Pmarszal GUDID Packaging - Two part package Other US Medical Device Regulations 5
M GUDID/UDI Packaging and Labeling Questions Other US Medical Device Regulations 6
C GUDID Device record history Medical Device and FDA Regulations and Standards News 2
D How to list multi-product sample pack in GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M GUDID data deficiency communication - IS THIS A SCAM? ISO 13485:2016 - Medical Device Quality Management Systems 29
S Which department manages Establishment Registration, Device Listing and GUDID? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M FDA News USFDA Proposes to End Temporary Extension of GUDID’s Grace Period Medical Device and FDA Regulations and Standards News 3
M Medical Device News FDA News - 27-08-18 - 2018 Learning program and GUDID updates Other US Medical Device Regulations 0
shimonv Commercialisation challenge related to FURLS & GUDID Other US Medical Device Regulations 0
M GUDID - Change in Quantity Other US Medical Device Regulations 0
Pmarszal Label Printing: Medical Device related UDI Requirements - GUDID Aspects Other US Medical Device Regulations 0
K GUDID / UDI and Company Relocation Other US Medical Device Regulations 3
I Request an FDA GUDID Account - Problems Other US Medical Device Regulations 3
I GUDID listing - Inputting data into the GUDID database Other US Medical Device Regulations 3
bio_subbu USFDA issues final guidance on Global Unique Device Identification Database (GUDID) Other US Medical Device Regulations 1
N Barcode Registration Requirements for Japan and GUDID Japan Medical Device Regulations 2
E Latex in packaging Other Medical Device Related Standards 2
H Expired packaging material - Expired unused Tyvek pouches Other Medical Device and Orthopedic Related Topics 2
A Packaging device with accessories already on the market Other Medical Device Regulations World-Wide 0
P Unrealistic Packaging Validation Sample Size 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 13
T Root Cause Failure Analysis - Not following Customer packaging Specification Problem Solving, Root Cause Fault and Failure Analysis 5
Q EU Rep for Packaging waste, WEEE and Battery disposal CE Marking (Conformité Européene) / CB Scheme 0
L AS5553 Clause 3.1.7 e "Control packaging material ..................reused" AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
L Packaging unsterile medical devices ISO 13485:2016 - Medical Device Quality Management Systems 6
M MDR - Packaging - Secondary Medical Device Boxes EU Medical Device Regulations 2
Y Packaging validation for non-sterile Medical Equipment Other Medical Device Related Standards 1
M UDI size on packaging EU Medical Device Regulations 3
M UDI placement - Packaging levels EU Medical Device Regulations 2
E Unit Dose Packaging Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
K Packaging and Damaged Parts returned from a Service Provider (Anodize) - Who is Responsible? Manufacturing and Related Processes 20
B 510(k) clearance claim on medical device product packaging Other US Medical Device Regulations 6
E Packaging Specifications Mercedes-Benz U.S. International IATF 16949 - Automotive Quality Systems Standard 4
TechnicalGuy Colour of symbols on Medical Device labelling and packaging Other Medical Device Related Standards 1
R Labels on sterile packaging EU Medical Device Regulations 5
A Interpretation of Article 16 (2b) - Packaging, samples and Certificate EU Medical Device Regulations 10
I Medical Device Packaging Multilingual Labeling EU Medical Device Regulations 3
N Process Flow diagram steps for inspection and packaging APQP and PPAP 4
C ISO 7010 m002 mandatory action - Color requirements on Packaging IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
shimonv GTIN Number on the Packaging of a Serviced Medical Device EU Medical Device Regulations 0
shimonv Is UDI required on the Packaging of a Serviced/Repaired Medical Device? Other US Medical Device Regulations 3
C QR Code on Medical Device Packaging and Notification to Notified Body EU Medical Device Regulations 1
TheMightyWife Address Change - Medical Device Packaging Labelling Requirements EU Medical Device Regulations 7
E Use of FDA Cleared logo on packaging US Food and Drug Administration (FDA) 8
V Tyvek packaging for Medical device process validation Qualification and Validation (including 21 CFR Part 11) 2
S Symbols - Device label versus Packaging label ISO 13485:2016 - Medical Device Quality Management Systems 1
Y Sterile device packaging under MDR EU Medical Device Regulations 3
A Packaging seal inspection Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A Capability Analysis for Packaging Seal Strength with spec. >0.1 Kgf using Minitab Using Minitab Software 6

Similar threads

Top Bottom