Catalog Number

-

Brand Name

Roscoe Medical

Version/Model Number

O2C5L

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

K090007

Product Code

CAW

Product Code Name

Generator, Oxygen, Portable

Public Device Record Key

33f9b958-0a44-40a8-a156-081501a6f2ec

Public Version Date

January 25, 2022

Public Version Number

1

DI Record Publish Date

January 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-