BLUE SPARK TECHNOLOGIES, INC.

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

No

Clear

TempTraq - 00851203006005 Catalog Number : 600

Device Description : Continuous Temperature Monitor

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TempTraq - 00851203006012 Catalog Number : 601

Device Description : Continuous Temperature Monitor

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TempTraq - 00851203006029 Catalog Number : 602

Device Description : Continuous Temperature Monitor

Device Class :

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 2

TempTraq - 00851203006036 Catalog Number :

Device Description : TempTraq Consumer Android App

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TempTraq - 00851203006043 Catalog Number :

Device Description : TempTraq Consumer iOS App

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TempTraq® - 00851203006067 Catalog Number : 606

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TempTraq® - 00851203006074 Catalog Number : 607

Device Class :

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 25

TempTraq® - 00851203006111 Catalog Number :

Device Description : TempTraq Patient Android App

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TempTraq® - 00851203006128 Catalog Number :

Device Description : TempTraq Clinician Android App

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

TempTraq® - 00851203006135 Catalog Number :

Device Description : TempTraq Patient iOS App

Device Class : 2

Duns Number: 603031365

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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