AccessGUDID - DEVICE: Oxygen Kit (00848530105808)

GUDID

Device Identifier (DI) Information

Brand Name: Oxygen Kit
Version or Model: ATRIUMHAHO2KIT-10
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ATRIUMHAHO2KIT-10
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530105808
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: Atrium At Home O2 Kits

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:	Yes
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
OGL	Oxygen Administration Kit

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: bff088b0-424a-41c8-bf33-a6b4924d0a72
Public Version Date: April 23, 2025
Public Version Number: 1
DI Record Publish Date: April 15, 2025