Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

I work in Regulatory Affairs department for a Medical Device manufacturing company in the US. I have a question about GUDID entry for a Medical Device I am responsible for. 

This particular model of the device consists of a medical device and an accessory both of which have their own separate GTIN on their pouch labels however they are both packaged together in a box that has its own GTIN. The GUDID new entry form has only one "primary DI" and one "secondary DI". Since I have two primary DIs and one secondary DI, how do I add enter the information into the GUDID portal? 

Any thoughts on how to approach this would be highly appreciated!

Thank you,
S

Hello S

No, it isn't a "secondary" UDI. That would be like if your device had both GTIN and HIBC.
See the definition in the data elements reference table:  https://www.fda.gov/medical-devices/global-unique-device-identification-database-gudid/gudid-guidance

It is possible your box may meet the definition of a convenience kit:  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-convenience-kits

If so, you can register the kit, and you don't have to register the device and accessory in GUDID, unless you may sometimes ship them separately. Note that even if the two pouches don't have to be registered in the GUDID, you could voluntarily enter them, too, if you think the information might be handy for a user.

When you enter the information, remember each record is all about a single GTIN. If you enter the box GTIN, everything you enter on that page is about the kit as a whole. If you enter a pouch GTIN, everything on that page is about the contents of that pouch.

------------------------------
Anne LeBlanc
United States
------------------------------

Original Message:
Sent: 07-Feb-2023 14:14
From: Anonymous Member
Subject: UDI/ GUDID

This message was posted by a user wishing to remain anonymous

Hello,

I work in Regulatory Affairs department for a Medical Device manufacturing company in the US. I have a question about GUDID entry for a Medical Device I am responsible for.

This particular model of the device consists of a medical device and an accessory both of which have their own separate GTIN on their pouch labels however they are both packaged together in a box that has its own GTIN. The GUDID new entry form has only one "primary DI" and one "secondary DI". Since I have two primary DIs and one secondary DI, how do I add enter the information into the GUDID portal?

Any thoughts on how to approach this would be highly appreciated!

Thank you,
S

This message was posted by a user wishing to remain anonymous

Hi Anne,

Thank you for your quick response! 

I want to clarify a few things from my previous post, The device model on the whole cannot be classified as a kit. The device and accessory which make up the "device" are not sold separately, and they can't function separately.

I do like the approach of just tracking the box GTIN as Primary DI because the box accounts for both the device and accessory inside and it is technically the base unit of packaging as we are claiming that they need to be used together in a procedure and it is just one unit altogether. The GTINs on the individual pouches inside are just for internal tracking. 

Thank you for the advice. Appreciate the help!

Sincerely,
S
Original Message:
Sent: 07-Feb-2023 18:40
From: Anne LeBlanc
Subject: UDI/ GUDID

Hello S

No, it isn't a "secondary" UDI. That would be like if your device had both GTIN and HIBC.
See the definition in the data elements reference table:  https://www.fda.gov/medical-devices/global-unique-device-identification-database-gudid/gudid-guidance

It is possible your box may meet the definition of a convenience kit:  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-convenience-kits

If so, you can register the kit, and you don't have to register the device and accessory in GUDID, unless you may sometimes ship them separately. Note that even if the two pouches don't have to be registered in the GUDID, you could voluntarily enter them, too, if you think the information might be handy for a user.

When you enter the information, remember each record is all about a single GTIN. If you enter the box GTIN, everything you enter on that page is about the kit as a whole. If you enter a pouch GTIN, everything on that page is about the contents of that pouch.

------------------------------
Anne LeBlanc
United States

Original Message:
Sent: 07-Feb-2023 14:14
From: Anonymous Member
Subject: UDI/ GUDID

This message was posted by a user wishing to remain anonymous

Hello,

I work in Regulatory Affairs department for a Medical Device manufacturing company in the US. I have a question about GUDID entry for a Medical Device I am responsible for.

This particular model of the device consists of a medical device and an accessory both of which have their own separate GTIN on their pouch labels however they are both packaged together in a box that has its own GTIN. The GUDID new entry form has only one "primary DI" and one "secondary DI". Since I have two primary DIs and one secondary DI, how do I add enter the information into the GUDID portal?

Any thoughts on how to approach this would be highly appreciated!

Thank you,
S

Hi,

When the 2 devices are packaged in a box, the box GTIN is the primary and can be included in GUDID. This is applicable as far as they are sold in single packaging. GTIN is the identity of the product that is readily from manufacturing through distribution to patient use. 

------------------------------
Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
------------------------------

Original Message:
Sent: 07-Feb-2023 14:14
From: Anonymous Member
Subject: UDI/ GUDID

This message was posted by a user wishing to remain anonymous

Hello,

I work in Regulatory Affairs department for a Medical Device manufacturing company in the US. I have a question about GUDID entry for a Medical Device I am responsible for.

This particular model of the device consists of a medical device and an accessory both of which have their own separate GTIN on their pouch labels however they are both packaged together in a box that has its own GTIN. The GUDID new entry form has only one "primary DI" and one "secondary DI". Since I have two primary DIs and one secondary DI, how do I add enter the information into the GUDID portal?

Any thoughts on how to approach this would be highly appreciated!

Thank you,
S