KAZ USA, INC.

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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) (7)

Premarket Exempt

No Yes

Clear

Vicks - 00328785502008 Catalog Number :

Device Description : VICKS STEAM INHALER

Device Class : 1

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Vicks - 00328785705201 Catalog Number :

Device Description : VICKS COOL MIST HUMIDIFIER, WHITE, JUVI VERSION

Device Class : 1

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

Vicks - 00328785707502 Catalog Number :

Device Description : HUMIDIFIER, WARM MIST, VICKS

Device Class : 1

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

PROTEC - 00328785808131 Catalog Number :

Device Description : FILTER, WICKING, WF813, PROTEC

Device Class : 1

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

PROTEC - 00328785835021 Catalog Number :

Device Description : HUMIDIFIER FILTER, WICKING, WF2, PROTEC

Device Class :

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 3

Vicks - 00328785990195 Catalog Number :

Device Description : Vicks VapoPads, Family Pack (Menthol)

Device Class :

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 6

vicks - 00328785999198 Catalog Number :

Device Description : VAPOPAD FAMILY PACK, MENTHOL, NEW UPC

Device Class : 1

Duns Number: 122612547

Premarket Exempt : Yes

Product Code : KFZ

Prescription Use : No

Device Count : 1

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