Publication Detail: M-20
Guideline for the Implementation of Unique Device Identification
Edition: 1
Published: February, 2017
Status: Available
Type: Standards and Specifications
Catalog group: Medical Gases
Size: 5 pages
Pricing:

N/A = not available
Member Subscriber Customer
Electronic: $0 $0 $21
Hardcopy $12 $21 $21
Publisher: CGA
Special attributes:
Notes:  
Task Panel   (your options for this publication)

  You may be entitled to free or discounted publications.
            Please login or register before shopping.

Download e-Pub (protected)

View Table of Contents (free)

View Free Content

Purchase e-Pub format

Purchase hardcopy format

Person not found: 0

Initializing check #1, person identity

Keyword #
medical device4
This publication describes the industry position of both manufacturers and distributors of medical devices used in the medical gas and gas equipment industry regarding 21 CFR Part 830 and associated guidance. It describes the industry’s interpretation and application of the requirements for the creation and maintenance of device barcodes and the submission of the related database records in electronic format. This pub-lication should be utilized to create a firm’s standard operating procedures (SOP) for compliance with the regulation.

This publication is based upon:
• 21 CFR Part 830 [1];
• FDA’s GUDID guidance [2]; and
• the Compressed Gas Association’s (CGA) letters to FDA regarding these issues dated November 1, 2012 and July 8, 2014.

This publication does not include guidance for implementation of UDI for standalone software. See 21 CFR Part 801 for guidance for standalone software.

This publication does not cover product codes BXK or NXF (i.e., gases used for calibration and other purposes). Gases included in these product codes are the subject of CGA’s letters to FDA dated November 1, 2012 and July 8, 2014.

Changes effective December 17, 2011

  • Simplified licensing
    • If you have already purchased this publication, or have a current e-Pub subscription
      • Click "Download e-Pub"
      • In your browser, select Save, Save As or Open (options vary by browser & personal settings)
      • Done!

  • Not yet purchased?
    • Add to Shopping Cart
    • Complete your purchase
    • Return here to download
    • Note that you can easily locate purchased publications via links on the Publication Selector page

  • Simplified maintenance
    • CGA e-Pubs are protected and licensed for specific computers
    • Periodically, the DRM (Digital Rights Management) software will re-verify your license
    • If your machine configuration has changed, or your CGA cookies have expired, you may be prompted for your User ID and password
      • Enter your email address and password registered with CGA
      • If you have any difficulty, or have forgotten your password, just return to the CGA Customer web-site and download the e-Pub again