Catalog Number

-

Brand Name

KINGFA

Version/Model Number

KF-B P05

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K201622,K201622,K201622

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

9d5406a7-405c-4329-827a-5ec262107449

Public Version Date

January 28, 2021

Public Version Number

2

DI Record Publish Date

December 22, 2020

Package DI Number

26973163400063

Quantity per Package

50

Contains DI Package

16973163400066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton