Catalog Number

-

Brand Name

Aerovent Plus®

Version/Model Number

CHC, cs/50

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

K110273,K110273

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

830443d1-f149-4617-a6bc-691fbcba9c53

Public Version Date

September 09, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

50604351858508

Quantity per Package

50

Contains DI Package

00604351858503

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-