Catalog Number

-

Brand Name

Moldex Airwave Surgical N95 Respirator

Version/Model Number

4150

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MSH

Product Code Name

Respirator, Surgical

Public Device Record Key

3da5115a-b3de-4352-a6cb-670659dfda2d

Public Version Date

March 07, 2022

Public Version Number

1

DI Record Publish Date

February 25, 2022

Package DI Number

50092311415005

Quantity per Package

10

Contains DI Package

00092311415000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-