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

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass (DRY) (10)

Premarket Exempt

Yes No

Clear

System M ® - 05060434420206 Catalog Number : 303-031-005

Device Description : Exhaust Module for use with Gas Modules as part of Gas Management System

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

System M ® - 05060434420237 Catalog Number : 3003-001-010

Device Description : SO2 SO2 Twin

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® System M ® - 05060434420602 Catalog Number : 51-000037-00

Device Description : Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 2m

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® System M ® - 05060434420619 Catalog Number : 51-000038-00

Device Description : Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 2m

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® System M ® - 05060434420626 Catalog Number : 51-000039-00

Device Description : Hb / SO2 Twin - Tube ID 1/4" x Wall 1/16" (OD 3/8") 2m

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® System M ® - 05060434420633 Catalog Number : 51-000040-00

Device Description : Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 2m

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® System M ® - 05060434420640 Catalog Number : 51-000041-00

Device Description : Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 1.3m

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® System M ® - 05060434420657 Catalog Number : 51-000042-00

Device Description : Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 1.3m

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® System M ® - 05060434420664 Catalog Number : 51-000043-00

Device Description : Hb / SO2 Twin - Tube ID 1/4" x Wall 1/16" (OD 3/8") 1.3m

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® System M ® - 05060434420671 Catalog Number : 51-000044-00

Device Description : Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 1.3m

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

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