Catalog Number

BRS2189

Brand Name

BRS Level 2 Procedure Mask with Ear Loops

Version/Model Number

850021617196

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)

-

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

2affb57a-abd2-4be2-a56a-5a8725d64cb7

Public Version Date

April 12, 2021

Public Version Number

1

DI Record Publish Date

April 02, 2021

Package DI Number

10850021617193

Quantity per Package

12

Contains DI Package

00850021617196

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case