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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 Workstation 12" Elite
SPECTRUM MEDICAL LIMITED
QWS12E
In Commercial Distribution

  • 05060434422309 ()
51-000094-00

  • Extracorporeal blood gas/pH monitor
Quantum Workstation 15"
SPECTRUM MEDICAL LIMITED
QWS15S
In Commercial Distribution

  • 05060434422293 ()
51-000093-00

  • Extracorporeal blood gas/pH monitor
Quantum Workstation 15" Lite
SPECTRUM MEDICAL LIMITED
QWS15L
In Commercial Distribution

  • 05060434422279 ()
51-000091-00

  • Extracorporeal blood gas/pH monitor
Quantum Pressure Sensor Assembly - 0.75m
SPECTRUM MEDICAL LIMITED
QPR2
In Commercial Distribution

  • 05060434422231 ()
51-000088-00

  • Extracorporeal blood gas/pH monitor
Quantum Pressure Sensor Assembly - 1.2m
SPECTRUM MEDICAL LIMITED
QPR5
In Commercial Distribution

  • 05060434423290 ()
51-000138-00

  • Extracorporeal blood gas/pH monitor
Quantum Pressure Sensor Assembly - 0.75m
SPECTRUM MEDICAL LIMITED
QPR4
In Commercial Distribution

  • 05060434423283 ()
51-000137-00

  • Extracorporeal blood gas/pH monitor
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
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 Workstation 15 Elite
SPECTRUM MEDICAL LIMITED
QWS15E
In Commercial Distribution

  • 05060434422521 ()
51-000100-00

  • Extracorporeal blood gas/pH monitor
Reservoir Level Sensor
SPECTRUM MEDICAL LIMITED
QLV1
In Commercial Distribution

  • 05060434420893 ()
43-000889

  • Extracorporeal blood gas/pH monitor
Quantum Pressure Sensor Assembly - 4.0m
SPECTRUM MEDICAL LIMITED
QPR1
In Commercial Distribution

  • 05060434420886 ()
43-000918

  • Extracorporeal blood gas/pH monitor
Quantum Diagnostic Exhaust for use with Quantum Dagnostic Modules
SPECTRUM MEDICAL LIMITED
QDE
In Commercial Distribution

  • 05060434420817 ()
51-000051-00

  • Extracorporeal blood gas/pH monitor
Quantum Workstation 12"
SPECTRUM MEDICAL LIMITED
QWS12
In Commercial Distribution

  • 05060434420718 ()
51-000031-00

  • Extracorporeal blood gas/pH monitor
Quantum Diagnostic Module
SPECTRUM MEDICAL LIMITED
QDM1
In Commercial Distribution

  • 05060434420701 ()
51-000023-00

  • Extracorporeal blood gas/pH monitor
Quantum Diagnostic Module - No Gas
SPECTRUM MEDICAL LIMITED
QDM2
In Commercial Distribution

  • 05060434420695 ()
51-000032-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 1.3m
SPECTRUM MEDICAL LIMITED
HBS1-130
In Commercial Distribution

  • 05060434420671 ()
51-000044-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 1/4" x Wall 1/16" (OD 3/8") 1.3m
SPECTRUM MEDICAL LIMITED
HBS2-130
In Commercial Distribution

  • 05060434420664 ()
51-000043-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 1/4" x Wall 3/32" (OD 7/16") 1.3m
SPECTRUM MEDICAL LIMITED
HBS3-130
In Commercial Distribution

  • 05060434420657 ()
51-000042-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 3/8" x Wall 3/32" (OD 9/16") 1.3m
SPECTRUM MEDICAL LIMITED
HBS4-130
In Commercial Distribution

  • 05060434420640 ()
51-000041-00

  • Extracorporeal blood gas/pH monitor
Hb / SO2 Twin - Tube ID 3/16" x Wall 1/16" (OD 5/16") 2m
SPECTRUM MEDICAL LIMITED
HBS1-200
In Commercial Distribution

  • 05060434420633 ()
51-000040-00

  • Extracorporeal blood gas/pH monitor
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
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
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
SO2 SO2 Twin
SPECTRUM MEDICAL LIMITED
SO2 Sensor
In Commercial Distribution

  • 05060434420237 ()
3003-001-010

  • Extracorporeal blood gas/pH monitor
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
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
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
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
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
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
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