Catalog Number

M2322

Brand Name

MEDICOM SAFEMASK N95

Version/Model Number

M2322

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)

Yes

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

3350f2cf-db07-4c7f-bfbc-6a09e4dcf12f

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

20686864028493

Quantity per Package

8

Contains DI Package

10686864028496

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER CASE