Catalog Number

32029-001

Brand Name

AVEA II

Version/Model Number

32029-001

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103211

Product Code

CBK

Product Code Name

Ventilator, Continuous, Facility Use

Public Device Record Key

bbbb91d7-c42e-4028-8290-29cb32779315

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-