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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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Thermal Regulating System
Gentherm Medical, LLC
233
In Commercial Distribution

  • 10613031861075 ()

  • Weight: 59.5 Kilogram
  • Weight: 131 Pound
  • Height: 95.3 Centimeter
  • Depth: 43.2 Centimeter
  • Width: 43.2 Centimeter
  • Height: 37.5 Inch
  • Depth: 17.0 Inch
  • Width: 17.0 Inch
86107

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Temperature management system used to lower or raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.
Gentherm Medical, LLC
25-01
In Commercial Distribution

  • 10613031860009 ()

  • Weight: 131 Pound
  • Height: 37.5 Inch
  • Depth: 17.0 Inch
  • Width: 17.0 Inch
86000

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Total Body Hyperthermia System
Gentherm Medical, LLC
111Z
In Commercial Distribution

  • 10613031861549 ()

  • Weight: 15.2 Kilogram
  • Weight: 33.5 Pound
  • Height: 46.9 Centimeter
  • Height: 18.5 Inch
  • Depth: 38.1 Centimeter
  • Depth: 15 Inch
  • Width: 22.9 Centimeter
  • Width: 9 Inch
86154

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03531
In Commercial Distribution

  • 17290012127332 ()
  • 77290012127334 ()
  • 07290012127335 ()
500-03531

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Calibration Test Unit
Medivance, Inc.
74100L
In Commercial Distribution

  • 00801741128967 ()
74100L

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Upgrade (v 2.0.1)
Medivance, Inc.
76500
In Commercial Distribution

  • 00801741127809 ()
76500

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Bracket Assembly
Medivance, Inc.
76300
In Commercial Distribution

  • 00801741127793 ()
76300

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, RS232 Cord
Medivance, Inc.
76200
In Commercial Distribution

  • 00801741127786 ()
76200

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Transmission Interface Module
Medivance, Inc.
76100
In Commercial Distribution

  • 00801741127779 ()
76100

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Transmission Interface Module Kit
Medivance, Inc.
76000
In Commercial Distribution

  • 00801741127762 ()
76000

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
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