Catalog Number

203314

Brand Name

Medicom Safemask

Version/Model Number

203314

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

5e9d638d-3184-439c-b5f4-60647705119f

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

January 28, 2022

Package DI Number

20686864056915

Quantity per Package

10

Contains DI Package

10686864056918

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case