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

No Yes

Clear

Quantum ® System M ® - 05060434420107 Catalog Number : H6XLE

Device Description : Tube ID 1/4" x Wall 1/16" (OD 3/8")

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® System M ® - 05060434420114 Catalog Number : H7XLH

Device Description : Tube ID 1/4" x Wall 3/32" (OD 7/16")

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® System M ® - 05060434420121 Catalog Number : H9XLM

Device Description : Tube ID 3/8" x Wall 3/32" (OD 9/16")

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® System M ® - 05060434420138 Catalog Number : H11XLD

Device Description : Tube ID 1/2" x Wall 3/32" (OD 11/16")

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

System M ® - 05060434420145 Catalog Number : 3003-030-UB9

Device Description : Ultra Low Flow - (0.05 - 0.5 L/min) - Ultra Low Flow Gas Module (3003-030-013) & Ultra Low Flow - (0.05 - 0.5 L/min) - Ultra Low Flow Gas Module (3003-030-013) & Exhaust Module (3003-031-005)

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

System M ® - 05060434420152 Catalog Number : 3003-030-LB9

Device Description : Low Flow - (0.5 - 3.0 L/min) - Low Flow Gas Module (3003-030-011) & Exhaust Modu Low Flow - (0.5 - 3.0 L/min) - Low Flow Gas Module (3003-030-011) & Exhaust Module (3003-031-005)

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

System M ® - 05060434420169 Catalog Number : 3003-030-HB9

Device Description : High Flow - (1.0 - 7.0 L/min) - High Flow Gas Module (3003-030-010) & Exhaust Mo High Flow - (1.0 - 7.0 L/min) - High Flow Gas Module (3003-030-010) & Exhaust Module (3003-031-005)

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

System M ® - 05060434420176 Catalog Number : 3003-030-013

Device Description : Ultra Low Flow - (0.05 - 0.5 L/min)

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

System M ® - 05060434420183 Catalog Number : 3003-030-011

Device Description : Low Flow - (0.5 - 3.0 L/min)

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

System M ® - 05060434420190 Catalog Number : 3003-030-010

Device Description : High Flow - (1.0 - 7.0 L/min)

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

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