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 - 00180104005795 Catalog Number :

Device Description : Air Innovations 1.8 Gal Top Fill Digital w/ Aroma Tray & Remote Control - Dragonfly

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005801 Catalog Number :

Device Description : Air Innovations 1.8 Gal Top Fill Digital w/ Aroma Tray & Remote Control - Pale Pink

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005818 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005825 Catalog Number :

Device Description : Air Innovations 1.8 Gal Top Fill Digital w/ Aroma Tray & Remote Control - Red Pepper

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005832 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005849 Catalog Number :

Device Description : Air Innovations 1.3gal SensaTouch Humidifier w/Aroma Tray - Black

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005856 Catalog Number :

Device Description : Air Innovations 1.3gal SensaTouch Humidifier w/Aroma Tray - Classic Blue

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005863 Catalog Number :

Device Description : Air Innovations 1.3gal SensaTouch Humidifier w/Aroma Tray - Cream

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005870 Catalog Number :

Device Description : Air Innovations 1.3gal SensaTouch Humidifier w/Aroma Tray - Platinum

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005887 Catalog Number :

Device Description : Air Innovations 1.3gal SensaTouch Humidifier w/Aroma Tray - Red Pepper

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

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