Finding UMDNS (Universal Medical Device Nomenclature System) Codes

[pflores]

I work for a small medical device manufacturing company. We have been asked for a UMDNS Code for 2 of our products and I've searched high and low and can't find codes specific to these products.

One of the products is our Anti-Fog Guard which is an anti-fog solution formulated, without alcohol, to provide excellent levels of anti-fog protection from distortion of endoscope glass optics. The solution is sterile but it's only purpose is anti-fog, not to sterilize the endoscope.

The other product is our Tracheal T-Tubes which are used as tracheal and stoma stents to aid in the rehabilitation of tracheal stenosis, to temporarily aid in laryngotracheal injuries and to support a reconstituted trachea.

I've also heard that these UMDNS Codes are only required for Class IIb products, is that true? Any comments/suggestions would be greatly appreciated!

 

[SteveK]

I work for a small medical device manufacturing company. We have been asked for a UMDNS Code for 2 of our products and I've searched high and low and can't find codes specific to these products.

One of the products is our Anti-Fog Guard which is an anti-fog solution formulated, without alcohol, to provide excellent levels of anti-fog protection from distortion of endoscope glass optics. The solution is sterile but it's only purpose is anti-fog, not to sterilize the endoscope.

The other product is our Tracheal T-Tubes which are used as tracheal and stoma stents to aid in the rehabilitation of tracheal stenosis, to temporarily aid in laryngotracheal injuries and to support a reconstituted trachea.

I've also heard that these UMDNS Codes are only required for Class IIb products, is that true? Any comments/suggestions would be greatly appreciated!

First off you can join ECRI (www.ecri.org) to access the UMDNS database (for free) – you just have to register. I found a number UMDNS for a Tracheal T-tube, but could not find anything for an anti-fog solution specifically. However, you can request a new term. I’m not including the T-tube number here as it could be construed as copyright.

As far as I am aware the codes are for all classes of medical devices - you will see when you get access. The database is basically an excel spreadsheet with the code number and basic definition in the separate columns.

Steve

 

[pflores]

Thank you so much! That was very helpful information. I have requested a new code for our anti-fog solution.

 

[Terysa]

What is the correct UMDNS code for Tracheostomy tube ? Is it 14096 ? Where can I research the UMDNS database ?

 

[Yurii]

Hi!
I work in company which is producing the hydrofilical gel, it is dermal filler.
It been used in plastic surgery: Breast augmentation , buttock augmentation,face procedure etc.

Now we should get UMDNS Code or GMDN code.
Pls., could some one help to determine it. We need it to get CE Mark.
It is very urgent

 

[Ajit Basrur]

Yurii,

I have deleted the other 2 multiple posts. Pls do not post the same question in multiple posts as you may not get directed responses.

Being a weekend here in the US, the activity is bit slow, so please be patient

 

[surawuth]

Hi
Can someone help me to get access to UMDNS database and I already became ECRI.org member??