Catalog Number

2015

Brand Name

MEDICOM SAFEMASK PREMIER

Version/Model Number

2015

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

f7dea8b4-decc-4fcd-8bd9-8638d59b6758

Public Version Date

April 19, 2022

Public Version Number

7

DI Record Publish Date

September 15, 2016

Package DI Number

20686864002950

Quantity per Package

10

Contains DI Package

10686864002953

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER CASE