Catalog Number

2025

Brand Name

Facemask with one way valve in hard shell carrying case

Version/Model Number

2025

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"

Yes

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

K010191,K010191

Product Code

CBP

Product Code Name

Valve, Non-Rebreathing

Public Device Record Key

a26e2962-1011-46dc-80b7-43ad68eb5b0a

Public Version Date

July 06, 2018

Public Version Number

4

DI Record Publish Date

February 13, 2017

Package DI Number

B0022000CC8

Quantity per Package

100

Contains DI Package

B002000CC0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case of 100