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

Thermometer, Electronic, Clinical (FLL) (10)

Premarket Exempt

No Yes

Clear

Vicks - 00328785000269 Catalog Number :

Device Description : Thermometer, 15 sec, Digital, Audio Fever Signal

Device Class :

Duns Number: 122612547

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Vicks - 00328785000276 Catalog Number :

Device Description : Thermometer, 8 sec speed read, w/ Fever Insight, BPA free

Device Class :

Duns Number: 122612547

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Vicks - 00328785000283 Catalog Number :

Device Description : Thermometer, Vicks SmartTemp digital, w/Bluetooth

Device Class :

Duns Number: 122612547

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Braun - 00328785000306 Catalog Number :

Device Description : Thermometer, Braun No Touch + Forehead

Device Class :

Duns Number: 122612547

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

BRAUN - 00328785000313 Catalog Number :

Device Description : Braun ThermoScan PC20 Probe Covers, for use with PRO3000 and PRO4000 series ther Braun ThermoScan PC20 Probe Covers, for use with PRO3000 and PRO4000 series thermometers. This package contains 20 probe covers. Not for resale.The probe cover is intended for use as a sanitary barrier between the thermometer and ear canal.

Device Class :

Duns Number: 122612547

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 20

Braun - 00328785000320 Catalog Number :

Device Description : Braun ThermoScan PRO6000 Ear Thermometer with small cradle - intended for interm Braun ThermoScan PRO6000 Ear Thermometer with small cradle - intended for intermittent measurement of temperature for patients of all ages, this thermometer is used with a probe cover that is used as a sanitary barrier between the thermometer and the ear canal. This package contains a thermometer that is "Direct Marked" with UDI Datamatrix 00328785000252 and a box of 20 probe covers.

Device Class :

Duns Number: 122612547

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Braun - 00328785000337 Catalog Number :

Device Description : Braun ThermoScan PRO6000 Ear Thermometer with large cradle - intended for interm Braun ThermoScan PRO6000 Ear Thermometer with large cradle - intended for intermittent measurement of temperature for patients of all ages, this thermometer is used with a probe cover that is used as a sanitary barrier between the thermometer and the ear canal. This package contains a thermometer that is "Direct Marked" with UDI Datamatrix 00328785000252 and 2 boxes of 20 probe covers each.

Device Class :

Duns Number: 122612547

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Braun - 00328785000344 Catalog Number :

Device Description : Braun ThermoScan PRO6000 Ear Thermometer with Small Cradle & Charging Station - Braun ThermoScan PRO6000 Ear Thermometer with Small Cradle & Charging Station - intended for intermittent measurement of temperature for patients of all ages, this thermometer is used with a probe cover that is used as a sanitary barrier between the thermometer and the ear canal. This package contains a thermometer that is "Direct Marked" with UDI Datamatrix 00328785000252 and a box of 20 probe covers.

Device Class :

Duns Number: 122612547

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Braun - 00328785000351 Catalog Number :

Device Description : Braun ThermoScan PRO6000 Ear Thermometer with large cradle and charging station Braun ThermoScan PRO6000 Ear Thermometer with large cradle and charging station - intended for intermittent measurement of temperature for patients of all ages, this thermometer is used with a probe cover that is used as a sanitary barrier between the thermometer and the ear canal. This package contains a thermometer that is "Direct Marked" with UDI Datamatrix 00328785000252 and 2 boxes of 20 probe covers each.

Device Class :

Duns Number: 122612547

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

BRAUN - 00328785000368 Catalog Number :

Device Description : Braun ThermoScan PC20 Probe Covers, for use with PRO6000 series thermometers. Th Braun ThermoScan PC20 Probe Covers, for use with PRO6000 series thermometers. This package contains 20 probe covers. Not for individual sale. The probe cover is intended for use as a sanitary barrier between the thermometer and ear canal.

Device Class :

Duns Number: 122612547

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 20

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