Inventory Control - FDA UDI - Medical Devices - We are looking for a Third party product that will help track and print item labels for new FDA UDI (Unique Device Identifier) system.

(0) Share

Report

Posted on by Jordan Taub

470

FDA has come out with a new set of rules for tracking Medical Devices called UDI. (not to be mistaken for IUD). It is a barcode or QR Code with visible /readable numbers that represent the serial number, lot number and unit production number, manufacture/ expiration dates and all pertinent company information, etc.

All MD's must have labels printed with this information on it.

We are looking for Third Party Software that integrates into GP to handle UDI. It would need full integration into BOM.

*This post is locked for comments

I have the same question (0)

All responses (8)

Answers (0)

Community Member on at

Like (0)

Report

Hi Jordan,

Did you get any replies to this?

One of our Dynamics GP clients is requesting the identical function/add-on.

Regards,

Joe Donlan (JEDonlan@SoftwareSources.com)

Was this reply helpful? Yes No
Community Member on at

Like (0)

Report

I will certainly let you know if I can locate a suitable add-on as well...

Regards,

Joe Donlan

Was this reply helpful? Yes No
Suggested answer

Frank Hamelly | MVP... 46,623 Super User 2025 Season 2 on at

Like (0)

Report

Have you contacted Panatrack? www.panatrack.com

Was this reply helpful? Yes No
Suggested answer

L Vail 65,271 on at

Like (0)

Report

How long is this field? The Item Master contains a field called Item Code that is 15 characters long. Would that work?

Kind regards,

Leslie

Was this reply helpful? Yes No
Community Member on at

Like (0)

Report

Hi Frank,

Thank You...we work with Panatrack's products, but never asked them about this...I will now...and I'll post my answer...

Thank You.

Joe Donlan,

SoftwareSources

Was this reply helpful? Yes No
Community Member on at

Like (0)

Report

Hi Leslie,

Thank You for that suggestion. We are aware of that field and considered using something like Extender for this, but do not want to reinvent the wheel, so to speak.

Regards,

Joe Donlan

Software Sources

Was this reply helpful? Yes No
Jordan Taub 470 on at

Like (0)

Report

Hi Leslie,

This system has to be comprehensive. It can work with Serial # and it will also require lot numbers, but the UDI numbers have to have coding like a UPC number and will need to auto count at time of manufacture. Example if I have 10 units, I will need a number that contains the manufacturer number, lot number, and count #. Each number is specific to a single unit. It will integrate with BOM and assign these UPC's or in FDA Cases UDI's to the Assemblies.

This system would also need to be used to print these codes on labels. This would need to be scalable as we aren't a huge company we don't need a labeling system that would run on a 200 unit per minute labeling system. We need something that would work on a more manual setup.

Was this reply helpful? Yes No
Jordan Taub 470 on at

Like (0)

Report

Hi Frank,

I'm in discussions with Panatrack right now. They have heard about the FDA UDI issue but haven't started building to address it. Seems we are first to express a true interest. The system would have to be scalable as I know we wouldn't use all the features that a normal system from Panatrack offers.

Was this reply helpful? Yes No