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) (8) Medical Device Data System (OUG) (2)

Premarket Exempt

No Yes

Clear

Quantum ® - 05060434420008 Catalog Number : 51-000001-00

Device Description : Quantum Workstation

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : Yes

Device Count : 1

System M ® - 05060434420015 Catalog Number : 3005-001-200

Device Description : Data Management Monitor

Device Class : 1

Duns Number: 516398679

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

System M ® - 05060434420022 Catalog Number : 3005-001-110

Device Description : Extracorporeal Blood Parameter Monitor

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® - 05060434420039 Catalog Number : 3008-001-010

Device Description : Quantum Data Management Unit

Device Class : 1

Duns Number: 516398679

Premarket Exempt : Yes

Product Code : OUG

Prescription Use : No

Device Count : 1

System M ® - 05060434420046 Catalog Number : 3005-001-122

Device Description : Extracorporeal Blood Parameter Monitor

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

System M ® - 05060434420053 Catalog Number : 3003-010-020

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

System M ® - 05060434420060 Catalog Number : 3003-010-021

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

System M ® - 05060434420077 Catalog Number : 3003-010-022

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

System M ® - 05060434420084 Catalog Number : 3003-010-023

Device Description : Tube ID 3/16" x Wall 1/16" (OD 5/16")

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

Quantum ® System M ® - 05060434420091 Catalog Number : H5XLA

Device Description : Tube ID 3/16" x Wall 1/16" (OD 5/16")

Device Class : 2

Duns Number: 516398679

Premarket Exempt : No

Product Code : DRY

Prescription Use : No

Device Count : 1

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