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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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CATHETER CF6-8-100 CLOSUREFAST
MEDTRONIC, INC.
CF6-8-100
In Commercial Distribution

  • 00763000552176 ()

  • Insertable length: 100 cm
  • Introducer sheath: 6 Fr
  • Heating element length: 8 cm
  • Minimum ID size: 2.0 mm
  • Heating element diameter: 2.0 mm


  • Peripheral vascular electrocautery catheter, single-use
CoolFlow SM.03.DTX Heat Transfer Fluid 1.5L
SPECTRUM MEDICAL LIMITED
SM.03.DTX
In Commercial Distribution

  • 05060434423757 ()
51-000089-00

  • Cardiopulmonary bypass system heating/cooling unit
Hose Kit - 9.5mm Bore 4.5m (kit of 2)
SPECTRUM MEDICAL LIMITED
52-000047-00
In Commercial Distribution

  • 05060434422491 ()
52-000047-00

  • Cardiopulmonary bypass system heating/cooling unit
Hose Kit - 9.5mm Bore 2.5m (kit of 2)
SPECTRUM MEDICAL LIMITED
52-000046-00
In Commercial Distribution

  • 05060434422484 ()
52-000046-00

  • Cardiopulmonary bypass system heating/cooling unit
Hose Kit - 12.5mm Bore 4.5m (kit of 2)
SPECTRUM MEDICAL LIMITED
52-000045-00
In Commercial Distribution

  • 05060434422477 ()
52-000045-00

  • Cardiopulmonary bypass system heating/cooling unit
Hose Kit - 12.5mm Bore 2.5m (kit of 2)
SPECTRUM MEDICAL LIMITED
52-000044-00
In Commercial Distribution

  • 05060434422460 ()
52-000044-00

  • Cardiopulmonary bypass system heating/cooling unit
Quantum Heater Cooler
SPECTRUM MEDICAL LIMITED
QHC1
In Commercial Distribution

  • 05060434420961 ()
51-000058-00

  • Cardiopulmonary bypass system heating/cooling unit
The Thermo-Electric Cooling (TEC) lid Module is used in conjunction with the CardioQuip Modular Cooler-Heater (MCH) to provide cooling to slow the melting of ice in the tank. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-11TEC
In Commercial Distribution

  • 00860000846134 ()


  • Cardiopulmonary bypass system heating/cooling unit
The CardioQuip Refrigeration Module is a module of the CardioQuip Modular Cooler-Heater (MCH) which creates an ice block in the tank in order to lower the temperature of the water. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-10RMS
In Commercial Distribution

  • 00860000846127 ()


  • Cardiopulmonary bypass system heating/cooling unit
The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-1000(m)
In Commercial Distribution

  • 00860000846110 ()


  • Cardiopulmonary bypass system heating/cooling unit
The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers, and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-1000(i)
In Commercial Distribution

  • 00860000846103 ()


  • Cardiopulmonary bypass system heating/cooling unit
No Description
LivaNova Deutschland GmbH
Water Tubing 25m
In Commercial Distribution

  • 04033817901549 ()


  • Cardiopulmonary bypass system heating/cooling unit
No Description
LivaNova Deutschland GmbH
3T 240V ~ / 60Hz
In Commercial Distribution

  • 04033817901112 ()


  • Cardiopulmonary bypass system heating/cooling unit
No Description
LivaNova Deutschland GmbH
3T 120V ~ / 60Hz
In Commercial Distribution

  • 04033817900528 ()


  • Cardiopulmonary bypass system heating/cooling unit
No Description
LivaNova Deutschland GmbH
3T 208V ~ / 60Hz
In Commercial Distribution

  • 04033817900511 ()


  • Cardiopulmonary bypass system heating/cooling unit
Hemotherm® Dual Reservoir Cooler/Heater (115V, 50Hz)
Gentherm Medical, LLC
400CE
In Commercial Distribution

  • 10613031860221 ()

  • Height: 32 Inch
  • Depth: 22 Inch
  • Width: 22 Inch
  • Weight: 198 Pound
  • Area/Surface Area: 484 Square inch
86022

  • Cardiopulmonary bypass system heating/cooling unit
Water fitting, quick-connect for use with oxygenation systems, straight
Terumo Cardiovascular Systems Corporation
131086
In Commercial Distribution

  • 00886799001769 ()
131086

  • Cardiopulmonary bypass system heating/cooling unit
Water fitting, quick-connect for use with oxygenation systems, right angle
Terumo Cardiovascular Systems Corporation
131078
In Commercial Distribution

  • 00886799001752 ()
131078

  • Cardiopulmonary bypass system heating/cooling unit
Water fitting, quick-connect for use with myocardial protection systems
Terumo Cardiovascular Systems Corporation
9439
In Commercial Distribution

  • 00886799001745 ()
9439

  • Cardiopulmonary bypass system heating/cooling unit
HX2 Temperature Control System Accessory Hose Kit
Terumo Cardiovascular Systems Corporation
809883
In Commercial Distribution

  • 00886799000908 ()
809883

  • Cardiopulmonary bypass system heating/cooling unit
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