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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Quantum ® System M ® - 05060434420626

Hb / SO2 Twin - Tube ID 1/4" x Wall 1/16" (OD 3/8") 2m
SPECTRUM MEDICAL LIMITED
HBS2-200
In Commercial Distribution

  • 05060434420626 ()
51-000039-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420619

Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 2m
SPECTRUM MEDICAL LIMITED
HBS3-200
In Commercial Distribution

  • 05060434420619 ()
51-000038-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420602

Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 2m
SPECTRUM MEDICAL LIMITED
HBS4-200
In Commercial Distribution

  • 05060434420602 ()
51-000037-00

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420237

SO2 SO2 Twin
SPECTRUM MEDICAL LIMITED
SO2 Sensor
In Commercial Distribution

  • 05060434420237 ()
3003-001-010

  • Extracorporeal blood gas/pH monitor

System M - 05060434420206

Exhaust Module for use with Gas Modules as part of Gas Management System
SPECTRUM MEDICAL LIMITED
Exhaust Module
In Commercial Distribution

  • 05060434420206 ()
3003-031-005

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420190

High Flow - (1.0 - 7.0 L/min)
SPECTRUM MEDICAL LIMITED
Gas Module
Not in Commercial Distribution

  • 05060434420190 ()
3003-030-010

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420183

Low Flow - (0.5 - 3.0 L/min)
SPECTRUM MEDICAL LIMITED
Gas Module
Not in Commercial Distribution

  • 05060434420183 ()
3003-030-011

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420176

Ultra Low Flow - (0.05 - 0.5 L/min)
SPECTRUM MEDICAL LIMITED
Gas Module
Not in Commercial Distribution

  • 05060434420176 ()
3003-030-013

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420169

High Flow - (1.0 - 7.0 L/min) - High Flow Gas Module (3003-030-010) & Exhaust Module (3003-031-005)
SPECTRUM MEDICAL LIMITED
Gas Management System
Not in Commercial Distribution

  • 05060434420169 ()
3003-030-HB9

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420152

Low Flow - (0.5 - 3.0 L/min) - Low Flow Gas Module (3003-030-011) & Exhaust Module (3003-031-005)
SPECTRUM MEDICAL LIMITED
Gas Management System
Not in Commercial Distribution

  • 05060434420152 ()
3003-030-LB9

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420145

Ultra Low Flow - (0.05 - 0.5 L/min) - Ultra Low Flow Gas Module (3003-030-013) & Exhaust Module (3003-031-005)
SPECTRUM MEDICAL LIMITED
Gas Management System
Not in Commercial Distribution

  • 05060434420145 ()
3003-030-UB9

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420138

Tube ID 1/2" x Wall 3/32" (OD 11/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420138 ()
H11XLD

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420121

Tube ID 3/8" x Wall 3/32" (OD 9/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420121 ()
H9XLM

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420114

Tube ID 1/4" x Wall 3/32" (OD 7/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420114 ()
H7XLH

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420107

Tube ID 1/4" x Wall 1/16" (OD 3/8")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420107 ()
H6XLE

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420091

Tube ID 3/16" x Wall 1/16" (OD 5/16")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420091 ()
H5XLA

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420084

Tube ID 3/16" x Wall 1/16" (OD 5/16")
SPECTRUM MEDICAL LIMITED
Hct / SO2 Sensor
Not in Commercial Distribution

  • 05060434420084 ()
3003-010-023

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420077

Tube ID 1/4" x Wall 1/16" (OD 3/8")
SPECTRUM MEDICAL LIMITED
Hct / SO2 Sensor
Not in Commercial Distribution

  • 05060434420077 ()
3003-010-022

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420060

Tube ID 1/4" x Wall 3/32" (OD 7/16")
SPECTRUM MEDICAL LIMITED
Hct / SO2 Sensor
Not in Commercial Distribution

  • 05060434420060 ()
3003-010-021

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420053

Tube ID 3/8" x Wall 3/32" (OD 9/16")
SPECTRUM MEDICAL LIMITED
Hct / SO2 Sensor
In Commercial Distribution

  • 05060434420053 ()
3003-010-020

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420046

Extracorporeal Blood Parameter Monitor
SPECTRUM MEDICAL LIMITED
M4
Not in Commercial Distribution

  • 05060434420046 ()
3005-001-122

  • Extracorporeal blood gas/pH monitor

System M ® - 05060434420022

Extracorporeal Blood Parameter Monitor
SPECTRUM MEDICAL LIMITED
M2
Not in Commercial Distribution

  • 05060434420022 ()
3005-001-110

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434420008

Quantum Workstation
SPECTRUM MEDICAL LIMITED
QWS
In Commercial Distribution

  • 05060434420008 ()
51-000001-00

  • Extracorporeal blood gas/pH monitor

CDI OneView™ Monitoring System - 10886799001872

CDI OneView™ Calibration Gas 2
Terumo Cardiovascular Systems Corporation
CDI747
In Commercial Distribution

  • 10886799001872 ()
CDI747

  • Cardiopulmonary bypass system blood tubing set

CDI OneView™ Monitoring System - 10886799001865

CDI OneView™ Calibration Gas 1
Terumo Cardiovascular Systems Corporation
CDI746
In Commercial Distribution

  • 10886799001865 ()
CDI746

  • Cardiopulmonary bypass system blood tubing set

Quantum - 05060434423306

Quantum Pressure Sensor Assembly - 2.0m
SPECTRUM MEDICAL LIMITED
QPR6
In Commercial Distribution

  • 05060434423306 ()
51-000139-00

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434423283

Quantum Pressure Sensor Assembly - 0.75m
SPECTRUM MEDICAL LIMITED
QPR4
In Commercial Distribution

  • 05060434423283 ()
51-000137-00

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434423009

Hb/SO2 Twin Sensor ID 1/4" x Wall 1/16" (OD 3/8") - V0.55m, A0.85m
SPECTRUM MEDICAL LIMITED
HBS2-050
In Commercial Distribution

  • 05060434423009 ()
51-000122-00

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434422989

Hb/SO2 Twin Sensor ID 3/8" x Wall 3/32" (OD 9/16") - V0.55m, A0.85m
SPECTRUM MEDICAL LIMITED
HBS4-050
In Commercial Distribution

  • 05060434422989 ()
51-000120-00

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434422309

Quantum Workstation 12" Elite
SPECTRUM MEDICAL LIMITED
QWS12E
In Commercial Distribution

  • 05060434422309 ()
51-000094-00

  • Extracorporeal blood gas/pH monitor
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