Catalog Number

-

Brand Name

Air Innovations

Version/Model Number

MH-419

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KFZ

Product Code Name

Humidifier, Non-Direct Patient Interface (Home-Use)

Public Device Record Key

3dbcd7a0-300f-4906-b25f-1c55a058f1eb

Public Version Date

July 26, 2021

Public Version Number

1

DI Record Publish Date

July 16, 2021

Package DI Number

10180104005716

Quantity per Package

6

Contains DI Package

00180104005719

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case