Catalog Number

IRC5PO2V

Brand Name

Invacare® Perfecto2™ Oxygen Concentrator

Version/Model Number

IRC5PO2V

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

-

Product Code

CAW

Product Code Name

Generator, Oxygen, Portable

Public Device Record Key

c86e671c-e6e0-4977-a23b-170ac2a385fd

Public Version Date

April 22, 2019

Public Version Number

4

DI Record Publish Date

September 16, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-