Catalog Number

Not Applicable

Brand Name

MedSource Face Mask

Version/Model Number

MS-12125

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"

-

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

QKR

Product Code Name

Face Mask Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Public Health Emergency

Public Device Record Key

623c85fa-6876-4460-bd00-42a30820aab1

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

April 30, 2021

Package DI Number

00816703024720

Quantity per Package

600

Contains DI Package

00816703024713

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case