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 - 00180104005894 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005900 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005917 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005924 Catalog Number :

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

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005931 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill with SensaTouch & Facial Mist Attachment - Black

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005948 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill with SensaTouch & Facial Mist Attachment - Cream

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005955 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill with SensaTouch & Facial Mist Attachment - Platinum

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005962 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill with SensaTouch & Facial Mist Attachment - Red Pepper

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005979 Catalog Number :

Device Description : Air Innovations 1.3 Gal Top Fill with SensaTouch & Facial Mist Attachment - Taupe

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Air Innovations - 00180104005986 Catalog Number :

Device Description : Air Innovations 1.2 Gal. Cool Mist Digital Top-Fill Ultrasonic Humidifier - White

Device Class : 1

Duns Number: 603158390

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

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