Catalog Number

779500

Brand Name

KENOREX

Version/Model Number

779500

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

Yes

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

K021442,K021442

Product Code

BTM

Product Code Name

Ventilator, Emergency, Manual (Resuscitator)

Public Device Record Key

df44ba03-47da-4009-b455-b095fb155453

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 02, 2016

Package DI Number

10866512000207

Quantity per Package

12

Contains DI Package

00866512000200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE