BLUE SPARK TECHNOLOGIES, INC.

Address:806 SHARON DR STE G,Westlake,OH,44145,US

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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

Clear

TempTraq® - 00851203006142 Catalog Number :

Device Description : TempTraq Clinician iOS App

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TempTraq® - 00851203006166 Catalog Number :

Device Class :

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 25

TempTraq® - 00851203006173 Catalog Number :

Device Description : TempTraq Clinician Web App

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TempTraq® - 00851203006197 Catalog Number : 619

Device Class :

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 12

TempTraq® - 00851203006203 Catalog Number : 620

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 15

TempTraq® - 00851203006210 Catalog Number : 621

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 30

Cell Therapy 360 Wearable Tech V1 - 00851203006227 Catalog Number : 622

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 10

Cell Therapy 360 Wearable Tech V1 - 00851203006234 Catalog Number :

Device Description : BMS CT360 Android Patient App

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Cell Therapy 360 Wearable Tech V1 - 00851203006241 Catalog Number :

Device Description : BMS CT360 iOS Patient App

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

Cell Therapy 360 Wearable Tech V1 - 00851203006258 Catalog Number :

Device Description : BMS CT360 iOS Clinician App

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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