Catalog Number

-

Brand Name

VentStar Oxylog 3000F (P) 190

Version/Model Number

5704964

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

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

K062267

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

ce7cc80c-d0cf-4626-8673-fb93722b52d3

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

June 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-