Catalog Number

TPO100B

Brand Name

Invacare® SOLO2™ Transportable Oxygen Concentrator

Version/Model Number

TPO100B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 29, 2015

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

-

Product Code

CAW

Product Code Name

Generator, Oxygen, Portable

Public Device Record Key

1d4785b9-91b8-4890-bb1e-d343c2ec0fa6

Public Version Date

April 20, 2020

Public Version Number

3

DI Record Publish Date

September 14, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-