Catalog Number

779504

Brand Name

KENOREX

Version/Model Number

779504

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K140370,K140370

Product Code

CAP

Product Code Name

Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

Public Device Record Key

9790c7e0-e735-4cd5-905c-5fecd8918519

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

00852244007365

Quantity per Package

20

Contains DI Package

10852244007362

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE