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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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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

Quantum - 05060434420893

Reservoir Level Sensor
SPECTRUM MEDICAL LIMITED
QLV1
In Commercial Distribution

  • 05060434420893 ()
43-000889

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434420886

Quantum Pressure Sensor Assembly - 4.0m
SPECTRUM MEDICAL LIMITED
QPR1
In Commercial Distribution

  • 05060434420886 ()
43-000918

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434420817

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 - 05060434420695

Quantum Diagnostic Module - No Gas
SPECTRUM MEDICAL LIMITED
QDM2
In Commercial Distribution

  • 05060434420695 ()
51-000032-00

  • Extracorporeal blood gas/pH monitor
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