AIR INNOVATIONS - Clean Mist 1.6G Digital Humidifier with Aroma - GREAT INNOVATIONS, LLC

Duns Number:603158390

Device Description: Clean Mist 1.6G Digital Humidifier with Aroma Tray - Black

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More Product Details

Catalog Number

-

Brand Name

AIR INNOVATIONS

Version/Model Number

MH-602A

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

0596c38c-678d-417d-b9a4-39501cce2dcf

Public Version Date

July 23, 2019

Public Version Number

1

DI Record Publish Date

July 15, 2019

Additional Identifiers

Package DI Number

10180104000919

Quantity per Package

6

Contains DI Package

00180104001247

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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