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) (3)

Premarket Exempt

Yes

Clear

Air Innovations - 00180104400217 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 - Red

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104400224 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 - Navy

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

AIR INNOVATIONS - 00180104600006 Catalog Number : N/A

Device Description : Clean Mist 1.3G Digital Humidifier with Aroma Tray - Blue

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

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