GREAT INNOVATIONS, LLC

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 - 00180104000011 Catalog Number :

Device Description : Air Innovations 2.2 Gal Top Fill Digital w/ Aroma Tray - Black

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000028 Catalog Number :

Device Description : Air Innovations 2.2 Gal Top Fill Digital w/ Aroma Tray - White

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000240 Catalog Number :

Device Description : Air Innovations 2.2 Gal Top Fill Digital w/ Aroma Tray - Red

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000257 Catalog Number :

Device Description : Air Innovations 2.2 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 - 00180104000264 Catalog Number :

Device Description : Air Innovations 2.2 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 - 00180104000295 Catalog Number :

Device Description : Air Innovations 2.2 Gal Top Fill Digital w/ Aroma Tray - Light Silver

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000301 Catalog Number :

Device Description : Air Innovations 1.6 Gal Top Fill Humidifier with Bluetooth - Black

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000318 Catalog Number :

Device Description : Air Innovations 1.6 Gal Top Fill Humidifier with Bluetooth - Platinum

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000325 Catalog Number :

Device Description : Air Innovations 1.6 Gal Top Fill Humidifier with Bluetooth - White

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104000332 Catalog Number :

Device Description : Air Innovations 1.6 Gal Top Fill Humidifier with Bluetooth - Wine

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

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