Catalog Number

-

Brand Name

Humidification holder assy

Version/Model Number

6692660

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151814,K180098

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

184a20fc-425a-4cb8-8be9-98e5d9db8cd1

Public Version Date

May 28, 2019

Public Version Number

4

DI Record Publish Date

February 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-