Catalog Number

-

Brand Name

MaxO2Vent

Version/Model Number

1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 30, 2019

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

K002951

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

1ff41216-9ab9-4fa0-9770-6c06cc081fb3

Public Version Date

November 22, 2019

Public Version Number

4

DI Record Publish Date

October 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-