AIR INNOVATIONS - Air Innovations Top Fill Bluetooth Speaker with - GREAT INNOVATIONS, LLC

Duns Number:603158390

Device Description: Air Innovations Top Fill Bluetooth Speaker with APP & Extension Nozzle - Navy

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More Product Details

Catalog Number

-

Brand Name

AIR INNOVATIONS

Version/Model Number

MH-906

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

0a56a8ed-235e-4549-ad7e-5d5a0c6f4e78

Public Version Date

October 18, 2019

Public Version Number

1

DI Record Publish Date

October 10, 2019

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