AccessGUDID - DEVICE: Oxygen Kit (00848530100650)

GUDID

Device Identifier (DI) Information

Brand Name: Oxygen Kit
Version or Model: AMCA001O2KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUNSET HEALTHCARE SOLUTIONS, INC.

Primary DI Number: 00848530100650
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 141668116 *Terms of Use

Device Description: RES012(2): RES003(1): HUM08 (1): RES032 (1): RES1107(2); RES3025G(2); RES035(1); RES050(2)

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
No Product Codes

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: 602df5ad-5d19-4d1e-95af-5671015a24c3
Public Version Date: July 23, 2024
Public Version Number: 1
DI Record Publish Date: July 15, 2024