Catalog Number

-

Brand Name

AIR INNOVATIONS

Version/Model Number

MH-801BA

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

9d322ff8-458a-4221-86d9-4e8e1d32aa6d

Public Version Date

July 23, 2019

Public Version Number

1

DI Record Publish Date

July 15, 2019

Package DI Number

10180104003309

Quantity per Package

4

Contains DI Package

00180104003302

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case