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 Jewett Blood Bank Refrigerator - 10816934020505 Catalog Number : JBB3004V

Device Description : Jewett 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 Jewett Blood Bank Refrigerator - 10816934020512 Catalog Number : JBB3004W

Device Description : Jewett 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 Jewett Blood Bank Refrigerator - 10816934020529 Catalog Number : JBB404A

Device Description : Jewett 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 Jewett Blood Bank Refrigerator - 10816934020536 Catalog Number : JBB404D

Device Description : Jewett 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 Jewett Blood Bank Refrigerator - 10816934020543 Catalog Number : JBB404V

Device Description : Jewett 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 Jewett Blood Bank Refrigerator - 10816934020550 Catalog Number : JBB404W

Device Description : Jewett 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 Jewett Blood Bank Refrigerator - 10816934020567 Catalog Number : JBB5004A

Device Description : Jewett 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 Jewett Blood Bank Refrigerator - 10816934020574 Catalog Number : JBB5004D

Device Description : Jewett 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 Jewett Blood Bank Refrigerator - 10816934020581 Catalog Number : JBB5004V

Device Description : Jewett 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 Jewett Blood Bank Refrigerator - 10816934020598 Catalog Number : JBB5004W

Device Description : Jewett 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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