GREAT INNOVATIONS, LLC

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Humidifier, Non-Direct Patient Interface (Home-Use) (KFZ) (10)

Premarket Exempt

Yes

Clear

AIR INNOVATIONS - 00180104000790 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000806 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000813 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104001247 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104001674 Catalog Number : N/A

Device Description : Great Innovations Clean Mist Digital Tabletop & Floor Standing Humidifier w/ Rem Great Innovations Clean Mist Digital Tabletop & Floor Standing Humidifier w/ Remote - Black

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104001681 Catalog Number :

Device Description : Clean Mist Digital Tabletop & Floor Standing Humidifier with Remote & Aroma Tray - Purple

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104001704 Catalog Number :

Device Description : Air Innovations Clean Mist Digital Tabletop & Floor Standing Humidifier w/ Remote - Red

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104001711 Catalog Number :

Device Description : Air Innovations Clean Mist Digital Tabletop & Floor Standing Humidifier w/ Remot Air Innovations Clean Mist Digital Tabletop & Floor Standing Humidifier w/ Remote - Platinum

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104001810 Catalog Number :

Device Description : Air Innovations Ultrasonic Digital Humidifier - Purple

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104001841 Catalog Number :

Device Description : Air Innovations Clean Mist Ultrasonic Humidifier - Black

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

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