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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 ® - 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

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 ® - 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 ® - 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
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