AccessGUDID - DEVICE: Oxyensure AC/DC Charger US (09353645401062)

GUDID

Device Identifier (DI) Information

Brand Name: Oxyensure AC/DC Charger US
Version or Model: 40106
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: RESMED ASIA PTE. LTD.

Primary DI Number: 09353645401062
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 AC/DC Charger US (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?
36545	Basic power supply, reusable	A device designed to receive alternating-current energy (AC-power) from a mains electricity power line and deliver one or more regulated direct-current outputs to supply devices with electrical energy. It typically consists of a step-up or step-down transformer, a rectifier, a filter, and an electronic regulator that keeps the voltage, current, or power output stable over a broad range of loads and input voltages. 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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6b74c684-5720-4498-8313-028d6bc0891b
Public Version Date: July 31, 2023
Public Version Number: 3
DI Record Publish Date: February 28, 2019