Catalog Number

-

Brand Name

Aerochamber Plus® Flow-Vu®

Version/Model Number

aVHC, Medium Mask, NFR, Single

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

K112010

Product Code

NVP

Product Code Name

Holding Chambers, Direct Patient Interface

Public Device Record Key

8cd4fdaf-d507-4ca0-8c34-dbebe7d4137a

Public Version Date

September 09, 2021

Public Version Number

4

DI Record Publish Date

October 10, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-