Catalog Number

-

Brand Name

Care

Version/Model Number

BFM-001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

dfd64a71-dd66-4bbc-9fa2-3aed7990cab0

Public Version Date

May 23, 2022

Public Version Number

2

DI Record Publish Date

December 29, 2021

Package DI Number

B754BFM0011

Quantity per Package

50

Contains DI Package

B754BFM001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner