Catalog Number

GS-100

Brand Name

Inogen At Home Stationary Concentrator

Version/Model Number

NCE

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

K132489

Product Code

CAW

Product Code Name

Generator, Oxygen, Portable

Public Device Record Key

554f244e-5d2e-4067-a60b-4ecb98f915c1

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 27, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-