SPECTRUM MEDICAL LIMITED

Address:HARRIER 4,METEOR BUSINESS PARK,GLOUCESTER Gloucestershire,GB

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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

Console, Heart-Lung Machine, Cardiopulmonary Bypass (DTQ) (4) Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass (DRY) (3) Controller, Temperature, Cardiopulmonary Bypass (DWC) (1) Gas Control Unit, Cardiopulmonary Bypass (DTX) (1) Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type (KFM) (1)

Premarket Exempt

No Yes

Clear

Quantum ® - 05060434420794 Catalog Number : 51-000011-00

Device Description : Quantum Roller Pump - 4 inch

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DTQ

Prescription Use : Yes

Device Count : 1

Quantum ® - 05060434420800 Catalog Number : 51-000003-00

Device Description : Quantum Pump Control Module

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DTQ

Prescription Use : Yes

Device Count : 1

Quantum ® - 05060434420817 Catalog Number : 51-000051-00

Device Description : Quantum Diagnostic Exhaust for use with Quantum Dagnostic Modules

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® - 05060434420824 Catalog Number : 51-000056-00

Device Description : Quantum Pump Frame 3 - Vienna

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DTQ

Prescription Use : Yes

Device Count : 1

Quantum - 05060434420879 Catalog Number : 51-000057-00

Device Description : Quantum Anaesthetic Gas Sensor

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DTX

Prescription Use : Yes

Device Count : 1

Quantum ® - 05060434420886 Catalog Number : 43-000918

Device Description : Quantum Pressure Sensor Assembly - 4.0m

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® - 05060434420893 Catalog Number : 43-000889

Device Description : Reservoir Level Sensor

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® - 05060434420954 Catalog Number : 51-000059-00

Device Description : Quantum Pump Frame 4 - New York

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DTQ

Prescription Use : Yes

Device Count : 1

Quantum - 05060434420961 Catalog Number : 51-000058-00

Device Description : Quantum Heater Cooler

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DWC

Prescription Use : Yes

Device Count : 1

Quantum - 05060434421821 Catalog Number : 51-000061-00

Device Description : Quantum Centrifugal Drive Medium Pressure

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : KFM

Prescription Use : Yes

Device Count : 1

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