Catalog Number

IO-400

Brand Name

Inogen One G4 Oxygen Concentrator

Version/Model Number

630

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K032818

Product Code

CAW

Product Code Name

Generator, Oxygen, Portable

Public Device Record Key

38822355-80aa-47e6-83ae-cf84e7317917

Public Version Date

April 20, 2020

Public Version Number

4

DI Record Publish Date

March 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-