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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 ® - 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

CDI OneView™ Monitoring System - 10886799001872

CDI OneView™ Calibration Gas 2
Terumo Cardiovascular Systems Corporation
CDI747
In Commercial Distribution

  • 10886799001872 ()
CDI747

  • Cardiopulmonary bypass system blood tubing set

CDI OneView™ Monitoring System - 10886799001865

CDI OneView™ Calibration Gas 1
Terumo Cardiovascular Systems Corporation
CDI746
In Commercial Distribution

  • 10886799001865 ()
CDI746

  • Cardiopulmonary bypass system blood tubing set

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 - 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 - 05060434422309

Quantum Workstation 12" Elite
SPECTRUM MEDICAL LIMITED
QWS12E
In Commercial Distribution

  • 05060434422309 ()
51-000094-00

  • 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 - 05060434420886

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

  • 05060434420886 ()
43-000918

  • 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 - 05060434420695

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

  • 05060434420695 ()
51-000032-00

  • Extracorporeal blood gas/pH monitor

Virtual Kit Number - 04033817903000

No Description
LivaNova Deutschland GmbH
B-Capta VENOUS ONLY
In Commercial Distribution

  • 04033817903000 ()


  • Extracorporeal blood gas/pH monitor

B-Capta - 04033817902836

No Description
LivaNova Deutschland GmbH
Sensor Module
In Commercial Distribution

  • 04033817902836 ()


  • Extracorporeal blood gas/pH monitor

B-Capta - 04033817901631

No Description
LivaNova Deutschland GmbH
Arterial Sensor
In Commercial Distribution

  • 04033817901631 ()


  • Extracorporeal blood gas/pH monitor

B-Capta - 04033817901624

No Description
LivaNova Deutschland GmbH
Venous Sensor
In Commercial Distribution

  • 04033817901624 ()


  • Extracorporeal blood gas/pH monitor

Virtual Kit Number - 04033817901617

No Description
LivaNova Deutschland GmbH
B-Capta FULL SYSTEM
In Commercial Distribution

  • 04033817901617 ()


  • Extracorporeal blood gas/pH monitor

B-CAPTA - 08033178113526

No Description
SORIN GROUP ITALIA SRL
3/8" ARTERIAL CUVETTE
In Commercial Distribution

  • 38033178113527 ()
  • 08033178113526 ()


  • Cardiopulmonary bypass system blood gas sensor

B-CAPTA - 08033178113519

No Description
SORIN GROUP ITALIA SRL
1/4" ARTERIAL CUVETTE
In Commercial Distribution

  • 38033178113510 ()
  • 08033178113519 ()


  • Cardiopulmonary bypass system blood gas sensor

B-CAPTA - 08033178113113

No Description
SORIN GROUP ITALIA SRL
1/2" VENOUS CUVETTE
In Commercial Distribution

  • 38033178113114 ()
  • 08033178113113 ()


  • Cardiopulmonary bypass system blood gas sensor

B-CAPTA - 08033178113106

No Description
SORIN GROUP ITALIA SRL
3/8" VENOUS CUVETTE
In Commercial Distribution

  • 38033178113107 ()
  • 08033178113106 ()


  • Cardiopulmonary bypass system blood gas sensor

B-CAPTA - 08033178113090

No Description
SORIN GROUP ITALIA SRL
1/4" VENOUS CUVETTE
In Commercial Distribution

  • 38033178113091 ()
  • 08033178113090 ()


  • Cardiopulmonary bypass system blood gas sensor

BMU 40 - 04037691676203

Y-Datacable kit (LEMO 2 x DE9 female) incl. adaptor kit. RS232-Isolator 4KV. The blood monitoring unit BMU 40 is used to monitor the patient’s key blood levels during extracorporeal circulation. On the basis of the blood levels, the user can immediately adjust the settings of the equipment being used, thereby increasing patient safety.
Maquet Cardiopulmonary AG
Y-Datacable kit (Lemo auf 2 x DE9f)
Not in Commercial Distribution

  • 04037691676203 ()
70104.5532

  • Extracorporeal blood gas/pH monitor

BMU 40 - 04037691469775

No Description
Maquet Cardiopulmonary AG
Holder arm 100 mm with adapter plate
Not in Commercial Distribution

  • 04037691469775 ()
701043405

  • Extracorporeal blood gas/pH monitor

BMU 40 - 04037691467207

No Description
Maquet Cardiopulmonary AG
Holder arm 6 mm with adapter plate
Not in Commercial Distribution

  • 04037691467207 ()
701043406

  • Extracorporeal blood gas/pH monitor

BMU 40 - 04037691447445

No Description
Maquet Cardiopulmonary AG
Holder arm 200 mm with adapter plate
Not in Commercial Distribution

  • 04037691447445 ()
701043404

  • Extracorporeal blood gas/pH monitor

BMU 40 - 04037691412238

No Description
Maquet Cardiopulmonary AG
BMU 40 Blood Monitoring Unit
Not in Commercial Distribution

  • 04037691412238 ()
701040852

  • Extracorporeal blood gas/pH monitor

BMU 40 - 04037691349305

No Description
Maquet Cardiopulmonary AG
BMU 40 Sensor 3/16"
Not in Commercial Distribution

  • 04037691349244 ()
  • 04037691349305 ()

  • Length: 116.8 Millimeter
  • Outer Diameter: 0.1875 Inch
70104.0851

  • Cardiopulmonary bypass system blood gas sensor

BMU 40 - 04037691349299

No Description
Maquet Cardiopulmonary AG
BMU 40 Sensor 1/4"
Not in Commercial Distribution

  • 04037691349237 ()
  • 04037691349299 ()

  • Outer Diameter: 0.25 Inch
  • Length: 116.7 Millimeter
70104.0850

  • Cardiopulmonary bypass system blood gas sensor

BMU 40 - 04037691349282

No Description
Maquet Cardiopulmonary AG
BMU 40 Sensor 3/8"
Not in Commercial Distribution

  • 04037691349220 ()
  • 04037691349282 ()

  • Length: 102.2 Millimeter
  • Outer Diameter: 0.375 Inch
70104.0849

  • Cardiopulmonary bypass system blood gas sensor

BMU 40 - 04037691349275

No Description
Maquet Cardiopulmonary AG
BMU 40 Cell 1/4"
Not in Commercial Distribution

  • 04037691349213 ()
  • 04037691349275 ()

  • Length: 124.2 Millimeter
  • Outer Diameter: 0.25 Inch
70104.0845

  • Cardiopulmonary bypass system blood gas sensor

BMU 40 - 04037691349268

No Description
Maquet Cardiopulmonary AG
BMU 40 Cell 3/8"
Not in Commercial Distribution

  • 04037691349206 ()
  • 04037691349268 ()

  • Outer Diameter: 0.375 Inch
  • Length: 135.8 Millimeter
70104.0844

  • Cardiopulmonary bypass system blood gas sensor

CDI OneView™ Monitoring System - 00886799002049

CDI OneView™ Touchscreen Display
Terumo Cardiovascular Systems Corporation
CDI751
In Commercial Distribution

  • 00886799002049 ()
CDI751

  • Extracorporeal blood gas/pH monitor

CDI OneView™ Monitoring System - 00886799002032

CDI OneView™ Core
Terumo Cardiovascular Systems Corporation
CDI750
In Commercial Distribution

  • 00886799002032 ()
CDI750

  • Extracorporeal blood gas/pH monitor

CDI OneView™ Monitoring System - 00886799002025

Calibrator Mounting Arm Bracket
Terumo Cardiovascular Systems Corporation
CDI783
In Commercial Distribution

  • 00886799002025 ()
CDI783

  • Portable active medical device mount

CDI OneView™ Monitoring System - 00886799002018

BPM Mounting Arm Bracket
Terumo Cardiovascular Systems Corporation
CDI782
In Commercial Distribution

  • 00886799002018 ()
CDI782

  • Portable active medical device mount

CDI OneView™ Monitoring System - 00886799002001

Display Mounting Arm Bracket
Terumo Cardiovascular Systems Corporation
CDI781
In Commercial Distribution

  • 00886799002001 ()
CDI781

  • Portable active medical device mount
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