Catalog Number

HYB591

Brand Name

N/A

Version/Model Number

HYB591

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

-

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

K062019,K062019

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

eae4af8b-9a77-4687-a6c0-fc18c8414a14

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 03, 2017

Package DI Number

10607411943802

Quantity per Package

15

Contains DI Package

00607411943805

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-