AccessGUDID - DEVICE: Oxyensure Backpack (09353645401024)

GUDID

Device Identifier (DI) Information

Brand Name: Oxyensure Backpack
Version or Model: 40102
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: RESMED ASIA PTE. LTD.

Primary DI Number: 09353645401024
Issuing Agency: GS1
Commercial Distribution End Date: July 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 659276906 *Terms of Use

Device Description: Oxyensure POC Backpack (AMO)

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?
37685	Personal device holder, reusable	A portable device designed to be worn or carried by a patient/layperson to hold a portable medical device (e.g., long-term recorder, wireless antenna, portable oxygen equipment, urine collection bag, tracheostoma protector, infusion pump) during ambulation or sleep; it is neither designed to hold an invasive tube/catheter to the skin surface (i.e., not a catheter/tube holder), nor to house and protect a device from damage (i.e., not a rigid case/housing). It is typically designed as a wearable bag, pouch, strap, belt, headband, or clothing, or as a trolley with wheels. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAW	Generator, Oxygen, Portable

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
Storage Environment Temperature: between 0 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 101 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d91ce6e8-f738-42c5-98c8-39c3f7f61dc3
Public Version Date: September 19, 2024
Public Version Number: 6
DI Record Publish Date: February 28, 2019