MEDICAL DEVICE TRACKER

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Suite 900, 1765 Greensboro Station Place,
McLean VA VA22101
United States

2018 Authentag LLC. All rights reserved

Welcome to the Authentag Apps Policy


Authentag currently operates Apps for Companies and Governments and under its own brand’s UDICheck, BluList, and Authentag.

By downloading our apps users agree to the following terms and conditions.

 

FDA Data

Our Apps directly access the Federal Drug Administration’s (FDA) Global Unique Device Identification Database GUDID database for details on the Medical Device they have just scanned.

We check with the FDA that the UDI you just scanned is correctly formatted. Then we access the real-time listing on the FDA’s GUDID for that Device Identifier and display it on your device for you.

This allows users to check that Device Identifiers registration status directly with the FDA.

Please note that, as this data comes directly from the FDA, it may not be accurate, it may not be available at the time of scanning and it may be incomplete. To state the obvious - whenever using any medical device you should consult a qualified physician if you are in any doubt about anything to do with its use or operation.

 

Managing Devices

Our Apps allow users to set the status of the device that they just scanned so that they, and other users can track it over time. This status plus the time and date and the location of that scan, along with a unique identity for your phone, is encrypted and sent to our cloud services for secure storage in Authentag’s patented anti-counterfeiting and recall system.

A digital chain of custody is then created which manufacturers can then store in their own file storage (Dropbox or Google Drive) in order to comply with the new rules on recalls from the FDA.

Manufacturers Information

Our Apps then check if the manufacturer of a device has filed any information with us about that device identifier. This information can consist of manuals, images, or external links to web pages or videos. We confirm if this user has permission to see that information and then display it to them as required.  Some manufacturers may require users to identify themselves before receiving information, or to have scanned a physical product or both.

Signing up and Signing in

Our Apps allow users to register or login with Single Sign On and link as many email address as required in order to identify themselves as either employees, customers or interested parties in medical devices. By Registering users can give up their anonymity, but may receive in return useful extra information about the products they have scanned. They are also granted access to our web services to trial our tracking capabilities and to review their account.

Data Collection

To perform the above operations we collect data about the medical devices you have scanned, about where you and when you scanned them, and about usage of the system in general. We share this information with both manufacturers and other third parties. We also analyse usage overtime. We do these things in order to provide the services outlined above.

 

We only collects the data necessary to perform tracking and recall activities.
 

Updates


We will update this app from time to time to ensure that it functions as your phone’s operating system is updated and also to give you more functionality. Use of the App means that you accept any such changes and also any changes to these terms and conditions.
 

Clarifications


We are not affiliated or related to the FDA or the FDA Accredited Issuing Agencies that currently control the creation and maintenance of UDI’s. We cannot change the details of a UDI on the FDA’s database and are not responsible for the quality or accuracy of the data drawn from the FDA’s GUDID database.

Up Time

We cannot guarantee this app will always work as the FDA GUDID database may not always be available for use in which case this App will not be able to check any details for you.
 

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