Charger DC/DC - Activox, Charger DC/DC - RESMED ASIA PTE. LTD.

Duns Number:659276906

Device Description: Activox, Charger DC/DC

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More Product Details

Catalog Number

-

Brand Name

Charger DC/DC

Version/Model Number

XYC104

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

519a479e-f4de-4432-af5d-523b4e0e313d

Public Version Date

April 20, 2020

Public Version Number

2

DI Record Publish Date

August 01, 2018

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