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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 TDM Quinidine - 07613336147917

No Description
Roche Diagnostics GmbH
08252670190
In Commercial Distribution

  • 07613336147917 ()
08252670190

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

ONLINE TDM Procainamide - 07613336147900

No Description
Roche Diagnostics GmbH
08252661190
In Commercial Distribution

  • 07613336147900 ()
08252661190

  • Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ONLINE TDM N-acetylprocainamide - 07613336147870

No Description
Roche Diagnostics GmbH
08252637190
In Commercial Distribution

  • 07613336147870 ()
08252637190

  • N-acetylprocainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

ONLINE TDM Amikacin - 07613336133514

No Description
Roche Diagnostics GmbH
08105383190
In Commercial Distribution

  • 07613336133514 ()
08105383190

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

ONLINE TDM Phenytoin - 07613336121474

No Description
Roche Diagnostics GmbH
08058601190
Not in Commercial Distribution

  • 07613336121474 ()
08058601190

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

ONLINE TDM Phenobarbital - 07613336121467

No Description
Roche Diagnostics GmbH
08058580190
In Commercial Distribution

  • 07613336121467 ()
08058580190

  • Phenobarbital IVD, kit, nephelometry/turbidimetry

ONLINE TDM Digoxin - 07613336121214

No Description
Roche Diagnostics GmbH
08057613190
In Commercial Distribution

  • 07613336121214 ()
08057613190

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

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 - 05060434423306

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

  • 05060434423306 ()
51-000139-00

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434423016

Hb/SO2 Twin Sensor ID 3/16" x Wall 1/16" (OD 5/16") - V0.55m, A0.85m
SPECTRUM MEDICAL LIMITED
HBS1-050
In Commercial Distribution

  • 05060434423016 ()
51-000123-00

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434422996

Hb/SO2 Twin Sensor ID 1/4" x Wall 3/32" (OD 7/16") - V0.55m, A0.85m
SPECTRUM MEDICAL LIMITED
HBS3-050
In Commercial Distribution

  • 05060434422996 ()
51-000121-00

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434422354

Quantum Pressure Sensor Assembly - 2.0m
SPECTRUM MEDICAL LIMITED
QPR3
In Commercial Distribution

  • 05060434422354 ()
51-000097-00

  • 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

Quantum - 05060434422293

Quantum Workstation 15"
SPECTRUM MEDICAL LIMITED
QWS15S
In Commercial Distribution

  • 05060434422293 ()
51-000093-00

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434422279

Quantum Workstation 15" Lite
SPECTRUM MEDICAL LIMITED
QWS15L
In Commercial Distribution

  • 05060434422279 ()
51-000091-00

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434422231

Quantum Pressure Sensor Assembly - 0.75m
SPECTRUM MEDICAL LIMITED
QPR2
In Commercial Distribution

  • 05060434422231 ()
51-000088-00

  • Extracorporeal blood gas/pH monitor

Quantum - 05060434423290

Quantum Pressure Sensor Assembly - 1.2m
SPECTRUM MEDICAL LIMITED
QPR5
In Commercial Distribution

  • 05060434423290 ()
51-000138-00

  • 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 - 05060434422521

Quantum Workstation 15 Elite
SPECTRUM MEDICAL LIMITED
QWS15E
In Commercial Distribution

  • 05060434422521 ()
51-000100-00

  • 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 ® - 05060434420718

Quantum Workstation 12"
SPECTRUM MEDICAL LIMITED
QWS12
In Commercial Distribution

  • 05060434420718 ()
51-000031-00

  • Extracorporeal blood gas/pH monitor

Quantum ® - 05060434420701

Quantum Diagnostic Module
SPECTRUM MEDICAL LIMITED
QDM1
In Commercial Distribution

  • 05060434420701 ()
51-000023-00

  • 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

Quantum ® System M ® - 05060434420671

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

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 ® - 05060434420657

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

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 ® - 05060434420633

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

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
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