Catalog Number

-

Brand Name

Aerochamber®

Version/Model Number

HC MV, 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

K900557,K900557

Product Code

CCQ

Product Code Name

Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Public Device Record Key

7805246c-b231-4070-ba3d-495180f1e1ac

Public Version Date

September 09, 2021

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

50604351985501

Quantity per Package

50

Contains DI Package

00604351985506

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-