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 - 00180104009670 Catalog Number :

Device Description : Air Innovations Top Fill 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 - 00180104009687 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104009694 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104009700 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill Manual Humidifier - Platinum

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104009717 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill Manual Humidifier - White

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104009724 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill Manual Humidifier - Black

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104009731 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill Manual Humidifier - Stone Blue

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104009748 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill Manual Humidifier - Red Pepper

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104400194 Catalog Number :

Device Description : Air Innovations Clean Mist Smart Humidifier with Aroma Tray & Ext Nozzle & Remot Air Innovations Clean Mist Smart Humidifier with Aroma Tray & Ext Nozzle & Remote Control - Black

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104400200 Catalog Number :

Device Description : Air Innovations Clean Mist Smart Humidifier with Aroma Tray & Ext Nozzle & Remot Air Innovations Clean Mist Smart Humidifier with Aroma Tray & Ext Nozzle & Remote Control - White

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

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