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 - 00180104000349 Catalog Number :

Device Description : Air Innovations 1.8 Gal Top Fill Digital w/ Aroma Tray - Platinum

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000356 Catalog Number :

Device Description : Air Innovations 1.8 Gal Top Fill Digital w/ Aroma Tray - Taupe

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000394 Catalog Number :

Device Description : Air Innovations 1.8 Gal Top Fill Digital w/ Aroma Tray - Wine

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000400 Catalog Number :

Device Description : Air Innovations 1.8 Gal Top Fill Digital w/ Aroma Tray - Cream

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000448 Catalog Number :

Device Description : Air Innovations 1.8 Gal Top Fill Digital w/ Aroma Tray - Stone Blue

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000455 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill with Sensatouch & Aroma Tray - Black

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000479 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill with Sensatouch & Aroma Tray - Platinum

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000486 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill with Sensatouch & Aroma Tray - Taupe

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000578 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill with Sensatouch & Aroma Tray - Blue

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000783 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

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