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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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ONLINE DAT Methaqualone - 07613336166109

No Description
Roche Diagnostics GmbH
08814708190
In Commercial Distribution

  • 07613336166109 ()
08814708190

  • Methaqualone IVD, reagent

ONLINE TDM Phenytoin - 07613336157787

No Description
Roche Diagnostics GmbH
08445567190
In Commercial Distribution

  • 07613336157787 ()
08445567190

  • Phenytoin therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Quantum ® - 05060434420701

Quantum Diagnostic Module
SPECTRUM MEDICAL LIMITED
QDM1
In Commercial Distribution

  • 05060434420701 ()
51-000023-00

  • Extracorporeal blood gas/pH monitor

Quantum ® System M ® - 05060434420664

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

Quantum ® System M ® - 05060434420640

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

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 ® - 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 - 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 ® - 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

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
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