Catalog Number

-

Brand Name

Meijer

Version/Model Number

4431284

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

K101128,K101128

Product Code

OUK

Product Code Name

Surgical Mask With Antimicrobial/Antiviral Agent

Public Device Record Key

a2301ea2-bb95-4643-b149-7920747e0b6e

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

December 28, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-