AccessGUDID - DEVICE: Oxygen Wrench (00628725097626)

GUDID

Device Identifier (DI) Information

Brand Name: Oxygen Wrench
Version or Model: VA-3045
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VA-3045
Company Name: Canadian Hospital Specialties Limited

Primary DI Number: 00628725097626
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 240992693 *Terms of Use

Device Description: OXYGEN WRENCH WITH SECURITY CHAIN

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60342	Gas line connection reference standard	A reference standard device intended to represent one end of a medical quick-connect coupling or a terminal unit of a gas-specific format [e.g., oxygen (O2), nitrous oxide (N2O), medical air], which may be used to evaluate connection port compatibility and integrity. It is designed with specific gas and device type mechanical mating patterns whereby it may also be used to test the medical gas pipeline integrity (i.e., test for leakage). It may consist of both a male end (to test a female socket) and female end (to test a male plug). This device is intended to be used by a professional in a professional setting (e.g., clinical engineering).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYX	Tubing, Pressure And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 202adf4b-93c7-4be5-b2d9-c38916490724
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 19, 2024