KEY SCIENTIFIC INC

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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 Revco Blood Bank Refrigerator - 10816934020109 Catalog Number : REB3004V

Device Description : Revco 29.2 Cu. Ft. Blood Bank Refrigerator, 230V/50Hz

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : Yes

Device Count : 1

Thermo Scientific Revco Blood Bank Refrigerator - 10816934020116 Catalog Number : REB3004W

Device Description : Revco 29.2 Cu. Ft. Blood Bank Refrigerator, 230V/50Hz

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : Yes

Device Count : 1

Thermo Scientific Revco Blood Bank Refrigerator - 10816934020123 Catalog Number : REB404A

Device Description : Revco 4.9 Cu. Ft. Blood Bank Refrigerator, 115V/60Hz

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : Yes

Device Count : 1

Thermo Scientific Revco Blood Bank Refrigerator - 10816934020130 Catalog Number : REB404D

Device Description : Revco 4.9 Cu. Ft. Blood Bank Refrigerator, 208/230V 60Hz

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : Yes

Device Count : 1

Thermo Scientific Revco Blood Bank Refrigerator - 10816934020147 Catalog Number : REB404V

Device Description : Revco 4.9 Cu. Ft. Blood Bank Refrigerator, 230V/50Hz

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : Yes

Device Count : 1

Thermo Scientific Revco Blood Bank Refrigerator - 10816934020154 Catalog Number : REB404W

Device Description : Revco 4.9 Cu. Ft. Blood Bank Refrigerator, 230V/50Hz

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : Yes

Device Count : 1

Thermo Scientific Revco Blood Bank Refrigerator - 10816934020161 Catalog Number : REB5004A

Device Description : Revco 51.1Cu. Ft. Blood Bank Refrigerator, 115V/60Hz

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : Yes

Device Count : 1

Thermo Scientific Revco Blood Bank Refrigerator - 10816934020178 Catalog Number : REB5004D

Device Description : Revco 51.1 Cu. Ft. Blood Bank Refrigerator, 208/230V 60Hz

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : Yes

Device Count : 1

Thermo Scientific Revco Blood Bank Refrigerator - 10816934020185 Catalog Number : REB5004V

Device Description : Revco 51.1 Cu. Ft. Blood Bank Refrigerator, 230V/50Hz

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : Yes

Device Count : 1

Thermo Scientific Revco Blood Bank Refrigerator - 10816934020192 Catalog Number : REB5004W

Device Description : Revco 51.1 Cu. Ft. Blood Bank Refrigerator, 230V/50Hz

Device Class : 2

Duns Number: 938286804

Premarket Exempt : Yes

Product Code : KSE

Prescription Use : Yes

Device Count : 1

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