Catalog Number

6200-U

Brand Name

Rescuer O-Mask

Version/Model Number

6200-U

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

KGB

Product Code Name

Mask, Oxygen, Non-Rebreathing

Public Device Record Key

cd880613-d42c-4bdb-9f75-b273d08d98d8

Public Version Date

April 09, 2021

Public Version Number

1

DI Record Publish Date

April 01, 2021

Package DI Number

B0026200U7

Quantity per Package

50

Contains DI Package

B0026200U0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton