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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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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
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
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