KEY SCIENTIFIC 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

Refrigerator, Freezer, Blood Storage (KSE) (10)

Premarket Exempt

No Yes

Clear

Thermo Scientific Forma - 10816934022578 Catalog Number : FDE60086MV

Device Description : Thermo Scientific Forma FDE Series -86C, 600 Box Capacity , 230V/50Hz; ENERGY ST Thermo Scientific Forma FDE Series -86C, 600 Box Capacity , 230V/50Hz; ENERGY STAR certified

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific HERAfreeze - 10816934022585 Catalog Number : HDE60086MA

Device Description : Thermo Scientific HERAfreeze HDE Series -86C, 600 Box Capacity , 115V/60Hz; ENER Thermo Scientific HERAfreeze HDE Series -86C, 600 Box Capacity , 115V/60Hz; ENERGY STAR certified

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific HERAfreeze - 10816934022592 Catalog Number : HDE60086MD

Device Description : Thermo Scientific HERAfreeze HDE Series -86C, 600 Box Capacity , 208-230V/60Hz; Thermo Scientific HERAfreeze HDE Series -86C, 600 Box Capacity , 208-230V/60Hz; ENERGY STAR certified

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific HERAfreeze - 10816934022608 Catalog Number : HDE60086MV

Device Description : Thermo Scientific HERAfreeze HDE Series -86C, 600 Box Capacity , 230V/50Hz; ENER Thermo Scientific HERAfreeze HDE Series -86C, 600 Box Capacity , 230V/50Hz; ENERGY STAR certified

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific - 10816934022615 Catalog Number : TDE60086MA

Device Description : Thermo Scientific TDE Series -86C, 600 Box Capacity , 115V/60Hz; ENERGY STAR certified

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific - 10816934022622 Catalog Number : TDE60086MD

Device Description : Thermo Scientific TDE Series -86C, 600 Box Capacity , 208-230V/60Hz; ENERGY STAR certified

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific - 10816934022639 Catalog Number : TDE60086MV

Device Description : Thermo Scientific TDE Series -86C, 600 Box Capacity , 230V/50Hz; ENERGY STAR certified

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific TSX Series High-Performance Plasma Freezer - 10816934022721 Catalog Number : TSX1230LA

Device Description : Thermo Scientific TSX Series High-Performance Plasma Freezer

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific TSX Series High-Performance Plasma Freezer - 10816934022738 Catalog Number : TSX1230LD

Device Description : Thermo Scientific TSX Series High-Performance Plasma Freezer

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

Thermo Scientific TSX Series High-Performance Plasma Freezer - 10816934022745 Catalog Number : TSX1230LY

Device Description : Thermo Scientific TSX Series High-Performance Plasma Freezer

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : No

Device Count : 1

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