Catalog Number

2021

Brand Name

MEDICOM SAFEMASK

Version/Model Number

2021

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

FXX

Product Code Name

Mask, surgical

Public Device Record Key

9e81c0d8-1682-4da0-8ced-056c7c6904a1

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

20686864010245

Quantity per Package

12

Contains DI Package

10686864010248

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER CASE