Catalog Number

FF1311

Brand Name

BYD CARE

Version/Model Number

FF1311

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2029

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)

Yes

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 (Except N95 Respirator) For General Public/Healthcare Personnel Per Iie Guidance

Public Device Record Key

f9d913fe-f9d0-45ee-82f7-24aedc76b014

Public Version Date

April 08, 2020

Public Version Number

1

DI Record Publish Date

March 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-