Catalog Number

10088

Brand Name

AVEA™

Version/Model Number

10088

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

K993449

Product Code

CBK

Product Code Name

Ventilator, continuous, facility use

Public Device Record Key

e4c9d389-3372-40dd-9375-f94155b39b8b

Public Version Date

October 24, 2022

Public Version Number

2

DI Record Publish Date

March 29, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-