Catalog Number

-

Brand Name

KENOREX

Version/Model Number

809960

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K142764,K142764

Product Code

CBP

Product Code Name

Valve, Non-Rebreathing

Public Device Record Key

1a4bef16-d5ea-481a-9806-cbeca8f9719a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 10, 2016

Package DI Number

10866512000238

Quantity per Package

36

Contains DI Package

00866512000231

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE