Catalog Number

-

Brand Name

Aero/Vent Max

Version/Model Number

AV-500M

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"

Yes

For Single-Use

Yes

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

K865107,K865107

Product Code

IYT

Product Code Name

System, Rebreathing, Radionuclide

Public Device Record Key

c9d8ac67-96e9-46ae-b187-3745c63532d5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 09, 2017

Package DI Number

00857863007260

Quantity per Package

24

Contains DI Package

00857863007093

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton