Air Innovations - Air Innovations Top Fill Humidifier with Aroma - GREAT INNOVATIONS, LLC

Duns Number:603158390

Device Description: Air Innovations Top Fill Humidifier with Aroma Tray - White

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More Product Details

Catalog Number

-

Brand Name

Air Innovations

Version/Model Number

MH-326

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KFZ

Product Code Name

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

Device Record Status

Public Device Record Key

7b9950df-896e-4a80-8958-52b42c13fe83

Public Version Date

July 26, 2021

Public Version Number

1

DI Record Publish Date

July 16, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GREAT INNOVATIONS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 81