Oxyensure AC/DC Charger US - Oxyensure POC AC/DC Charger US (AMO) - RESMED ASIA PTE. LTD.

Duns Number:659276906

Device Description: Oxyensure POC AC/DC Charger US (AMO)

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More Product Details

Catalog Number

-

Brand Name

Oxyensure AC/DC Charger US

Version/Model Number

40106

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CAW

Product Code Name

Generator, Oxygen, Portable

Device Record Status

Public Device Record Key

6b74c684-5720-4498-8313-028d6bc0891b

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

February 28, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESMED ASIA PTE. LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16