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 - 00180104009069 Catalog Number :

Device Description : Air Innovations 1.6 Gal Top Fill Humidifier with SensaTouch - Light Silver

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104009076 Catalog Number :

Device Description : Air Innovations 1.6 Gal Top Fill Humidifier with SensaTouch - Mint

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104009441 Catalog Number :

Device Description : Clean Mist 1.6G Top Fill Digital Humidifier with Aroma Tray - Platinum

Device Class :

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104009588 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 - 00180104009618 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 - 00180104009625 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104009632 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104009649 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill with SensaTouch - Sand

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104009656 Catalog Number :

Device Description : Air Innovations Top Fill Humidifier with Aroma Tray - Platinum

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104009663 Catalog Number :

Device Description : Air Innovations Top Fill Humidifier with Aroma Tray - White

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

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