Catalog Number

779501

Brand Name

KENOREX

Version/Model Number

779501

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

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

0c07e37f-1c35-42cf-9cc1-9f53028ca065

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 02, 2016

Package DI Number

10866512000214

Quantity per Package

12

Contains DI Package

00866512000217

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE