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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"
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
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 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 3/16" 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 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
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
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
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
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
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
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
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
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
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
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
Extracorporeal Blood Parameter Monitor
SPECTRUM MEDICAL LIMITED
M4
Not in Commercial Distribution

  • 05060434420046 ()
3005-001-122

  • Extracorporeal blood gas/pH monitor
Extracorporeal Blood Parameter Monitor
SPECTRUM MEDICAL LIMITED
M2
Not in Commercial Distribution

  • 05060434420022 ()
3005-001-110

  • Extracorporeal blood gas/pH monitor
Quantum Workstation
SPECTRUM MEDICAL LIMITED
QWS
In Commercial Distribution

  • 05060434420008 ()
51-000001-00

  • 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 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 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 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 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
No Description
Terumo Cardiovascular Systems Corporation
6913
In Commercial Distribution

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


  • Cardiopulmonary bypass system blood gas sensor
No Description
Terumo Cardiovascular Systems Corporation
CV-6914
In Commercial Distribution

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


  • Cardiopulmonary bypass system blood gas sensor
No Description
Terumo Cardiovascular Systems Corporation
CV-6913
In Commercial Distribution

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


  • Cardiopulmonary bypass system blood gas sensor
No Description
Terumo Cardiovascular Systems Corporation
6934
In Commercial Distribution

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


  • Cardiopulmonary bypass system blood gas sensor
No Description
Terumo Cardiovascular Systems Corporation
6933
In Commercial Distribution

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


  • Cardiopulmonary bypass system blood gas sensor
No Description
Terumo Cardiovascular Systems Corporation
CDI510H
In Commercial Distribution

  • 50699753160762 ()
  • 00699753160767 ()


  • Cardiopulmonary bypass system blood gas sensor
No Description
Terumo Cardiovascular Systems Corporation
6914
In Commercial Distribution

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


  • Cardiopulmonary bypass system blood gas sensor
No Description
Terumo Cardiovascular Systems Corporation
6912
In Commercial Distribution

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


  • Cardiopulmonary bypass system blood gas sensor
No Description
Terumo Cardiovascular Systems Corporation
CV-6912
In Commercial Distribution

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


  • Cardiopulmonary bypass system blood gas sensor
No Description
Terumo Cardiovascular Systems Corporation
6932
In Commercial Distribution

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


  • Cardiopulmonary bypass system blood gas sensor
TRILLIUM TMC50T W/EXT LINE
MEDTRONIC, INC.
TMC50T
Not in Commercial Distribution

  • 20721902358948 ()
  • 00721902358944 ()


  • Cardiopulmonary bypass system blood gas sensor
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
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
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
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
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
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