Catalog Number

-

Brand Name

Aero/Vent Plus

Version/Model Number

AV-1010

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

-

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

Product Code

IYT

Product Code Name

System, Rebreathing, Radionuclide

Public Device Record Key

fc627721-25ce-4265-a36e-1780ffdc5e8f

Public Version Date

August 05, 2022

Public Version Number

4

DI Record Publish Date

June 09, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-