AccessGUDID - DEVICE: Amron Oxygen Treatment Hood (00860010778609)

GUDID

Device Identifier (DI) Information

Brand Name: Amron Oxygen Treatment Hood
Version or Model: 8891-03S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Amron International, Inc.

Primary DI Number: 00860010778609
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086003852 *Terms of Use

Device Description: 02 VINYL HOOD W/OPTICAL WINDOW, NECK RING ASSEMBLY, STRAPS AND UNTRIMMED SILICONE NECK SEAL

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:	No
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?
45543	Oxygen administration hood, adult	A device consisting of a rigid transparent plastic shell forming an enclosure over the head of an adult, typically to provide an enriched oxygen (O2)environment to increase the patient's O2 uptake. It is connected to an O2 source and may be used concurrently with increased humidification and temperature control. It is designed for a variety of situations: 1) for those adverse to oxygen delivery devices such as a nasal cannula or face mask; 2) for use inside hyperbaric chambers; 3) for specific pulmonary testing. It may include the tubing, a diffuser (to disperse the flow of incoming O2), O2 concentration and humidity sensors, and audio listening facilities. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOG	Hood, Oxygen, Infant

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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: 9eeb9501-9660-4c20-88b9-c946798bb290
Public Version Date: August 18, 2023
Public Version Number: 1
DI Record Publish Date: August 10, 2023