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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 ® - 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 ® - 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 ® - 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 ® - 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

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

Quantum ® System M ® - 05060434420107

Tube ID 1/4" x Wall 1/16" (OD 3/8")
SPECTRUM MEDICAL LIMITED
Flow & Emboli Sensor
In Commercial Distribution

  • 05060434420107 ()
H6XLE

  • 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

System M ® - 05060434420084

Tube ID 3/16" x Wall 1/16" (OD 5/16")
SPECTRUM MEDICAL LIMITED
Hct / SO2 Sensor
Not in Commercial Distribution

  • 05060434420084 ()
3003-010-023

  • Extracorporeal blood gas/pH monitor

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

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

CDI™ H/S Cuvette 3/8 x 3/8 - 00699753270152

No Description
Terumo Cardiovascular Systems Corporation
6913
In Commercial Distribution

  • 50699753270157 ()
  • 30699753270153 ()
  • 00699753270152 ()


  • Cardiopulmonary bypass system blood gas sensor

CDI™ H/S Cuvette 1/4 x 1/4 - Japan - 00699753270138

No Description
Terumo Cardiovascular Systems Corporation
CV-6914
In Commercial Distribution

  • 50699753270133 ()
  • 30699753270139 ()
  • 00699753270138 ()


  • Cardiopulmonary bypass system blood gas sensor

CDI™ H/S Cuvette 3/8 x 3/8 - Japan - 00699753270121

No Description
Terumo Cardiovascular Systems Corporation
CV-6913
In Commercial Distribution

  • 50699753270126 ()
  • 30699753270122 ()
  • 00699753270121 ()


  • Cardiopulmonary bypass system blood gas sensor

CDI™ H/S Cuvette 1/4 x 1/4 with Extension - 00699753269040

No Description
Terumo Cardiovascular Systems Corporation
6934
In Commercial Distribution

  • 50699753269045 ()
  • 30699753269041 ()
  • 00699753269040 ()


  • Cardiopulmonary bypass system blood gas sensor

CDI™ H/S Cuvette 3/8 x 3/8 with Extension - 00699753269033

No Description
Terumo Cardiovascular Systems Corporation
6933
In Commercial Distribution

  • 50699753269038 ()
  • 30699753269034 ()
  • 00699753269033 ()


  • Cardiopulmonary bypass system blood gas sensor

CDI™ Shunt Sensor - 00699753160767

No Description
Terumo Cardiovascular Systems Corporation
CDI510H
In Commercial Distribution

  • 50699753160762 ()
  • 00699753160767 ()


  • Cardiopulmonary bypass system blood gas sensor

CDI™ H/S Cuvette 1/4 x 1/4 - 00699753270169

No Description
Terumo Cardiovascular Systems Corporation
6914
In Commercial Distribution

  • 50699753270164 ()
  • 30699753270160 ()
  • 00699753270169 ()


  • Cardiopulmonary bypass system blood gas sensor

CDI™ H/S Cuvette 1/2 x 1/2 - 00699753270145

No Description
Terumo Cardiovascular Systems Corporation
6912
In Commercial Distribution

  • 50699753270140 ()
  • 30699753270146 ()
  • 00699753270145 ()


  • Cardiopulmonary bypass system blood gas sensor

CDI™ H/S Cuvette 1/2 x 1/2 - Japan - 00699753270114

No Description
Terumo Cardiovascular Systems Corporation
CV-6912
In Commercial Distribution

  • 50699753270119 ()
  • 30699753270115 ()
  • 00699753270114 ()


  • Cardiopulmonary bypass system blood gas sensor

CDI™ H/S Cuvette 1/2 x 1/2 with Extension - 00699753269026

No Description
Terumo Cardiovascular Systems Corporation
6932
In Commercial Distribution

  • 50699753269021 ()
  • 30699753269027 ()
  • 00699753269026 ()


  • Cardiopulmonary bypass system blood gas sensor

TRILLIUM™ - 00721902358944

TRILLIUM TMC50T W/EXT LINE
MEDTRONIC, INC.
TMC50T
Not in Commercial Distribution

  • 20721902358948 ()
  • 00721902358944 ()


  • Cardiopulmonary bypass system blood gas sensor

TRILLIUM™ - 00721902358913

CONN TMC25T TRL WITH EXTENSION LINE 10PK
MEDTRONIC, INC.
TMC25T
Not in Commercial Distribution

  • 20721902358917 ()
  • 00721902358913 ()

  • 152 MM Tubing Length


  • Cardiopulmonary bypass system blood gas sensor

TMC38 - 00643169790711

TUBING CB4715R1 10PK CB TMC38 W/6INCH LN
MEDTRONIC, INC.
CB4715R1
Not in Commercial Distribution

  • 20643169790722 ()
  • 00643169790711 ()

  • Length: 15.2 Centimeter


  • Cardiopulmonary bypass system blood tubing set

TMC25 - 00643169790698

TUBING CB4714R1 10PK CB TMC25 W/6INCH LN
MEDTRONIC, INC.
CB4714R1
Not in Commercial Distribution

  • 20643169790708 ()
  • 00643169790698 ()

  • Length: 15.2 Centimeter


  • Cardiopulmonary bypass system blood tubing set

TMC50 - 00643169790674

TUBING CB4716R1 10PK CB TMC50 W/6INCH LN
MEDTRONIC, INC.
CB4716R1
Not in Commercial Distribution

  • 20643169790685 ()
  • 00643169790674 ()

  • Length: 15.2 Centimeter


  • Cardiopulmonary bypass system blood tubing set

NA - 00673978564210

TUBING CB4716R1 10PK CB TMC50 W/6INCH LN
MEDTRONIC, INC.
CB4716R1
Not in Commercial Distribution

  • 20673978564214 ()
  • 00673978564210 ()

  • Length: 152.0 Millimeter


  • Cardiopulmonary bypass system blood tubing set

NA - 00673978564173

TUBING CB4714R1 10PK CB TMC25 W/6INCH LN
MEDTRONIC, INC.
CB4714R1
Not in Commercial Distribution

  • 20673978564177 ()
  • 00673978564173 ()

  • Length: 152.0 Millimeter


  • Cardiopulmonary bypass system blood tubing set

NA - 00673978538426

CELL 1475R1 TMC50 W/6 INCH EXTENSION
MEDTRONIC, INC.
1475R1
In Commercial Distribution

  • 20673978538420 ()
  • 00673978538426 ()


  • Extracorporeal membrane oxygenator
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