AccessGUDID - DEVICE: Cylinder Wrenches for Tank Valve

GUDID

Device Identifier (DI) Information

Brand Name: Cylinder Wrenches for Tank Valve - Without Chain
Version or Model: RES032
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RES032
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530060541
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Cylinder Wrenches for Tank Valve - Without Chain (10/pack)

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":	No
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?
60856	Oxygen administration kit	A collection of devices designed for oxygen (O2) delivery that may include a mask, a nasal cannula, oxygen tubing, disposable non-prefilled humidifier and connectors. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAT	Cannula, Nasal, Oxygen

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
Special Storage Condition, Specify: Fragile

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 800cc

Device Record Status

Public Device Record Key: 45870c7b-4591-4765-be06-354e0f71651e
Public Version Date: February 05, 2024
Public Version Number: 2
DI Record Publish Date: July 31, 2018