BIOSYNERGY, 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

Regulator, Temperature (JRR) (3) Strip, Temperature, Forehead, Liquid Crystal (KPD) (3) Refrigerator, Freezer, Blood Storage (KSE) (2) Block, Heating (JRG) (1) Supplies, Blood-Bank (KSS) (1)

Premarket Exempt

No Yes

Clear

TempTrend - M74410001 Catalog Number :

Device Class :

Duns Number: 070698154

Premarket Exempt : No

Product Code : KPD

Prescription Use : No

Device Count : 50

TempTrend - M74410004 Catalog Number :

Device Class :

Duns Number: 070698154

Premarket Exempt : No

Product Code : KPD

Prescription Use : No

Device Count : 1000

TempTrend II - M74411001 Catalog Number :

Device Class :

Duns Number: 070698154

Premarket Exempt : No

Product Code : KPD

Prescription Use : No

Device Count : 50

HemoTemp - M74420001 Catalog Number :

Device Class :

Duns Number: 070698154

Premarket Exempt : No

Product Code : KSE

Prescription Use : No

Device Count : 40

HemoTemp II - M74430001 Catalog Number :

Device Class :

Duns Number: 070698154

Premarket Exempt : No

Product Code : KSS

Prescription Use : No

Device Count : 40

StaFreez - M74450001 Catalog Number :

Device Class :

Duns Number: 070698154

Premarket Exempt : Yes

Product Code : JRR

Prescription Use : No

Device Count : 50

LabTemp 20 - M74460001 Catalog Number :

Device Class :

Duns Number: 070698154

Premarket Exempt : Yes

Product Code : JRR

Prescription Use : No

Device Count : 50

LabTemp 40 - M74461001 Catalog Number :

Device Class :

Duns Number: 070698154

Premarket Exempt : Yes

Product Code : JRR

Prescription Use : No

Device Count : 50

HemoCool Gel-Pak - M74481000 Catalog Number : 8100

Device Class : 2

Duns Number: 070698154

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

HemoTemp II Activator - M74490000 Catalog Number :

Device Class : 1

Duns Number: 070698154

Premarket Exempt : Yes

Product Code : JRG

Prescription Use : No

Device Count : 1

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