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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Arctic Sun® Temperature Management System, Temperature Cable Bard
Medivance, Inc.
73503
In Commercial Distribution

  • 00801741080302 ()
73503

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Strap Kit, Fluid Delivery Line
Medivance, Inc.
73490
In Commercial Distribution

  • 00801741080289 ()
73490

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Power Cord
Medivance, Inc.
73300
In Commercial Distribution

  • 00801741080258 ()
73300

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Drain Tube
Medivance, Inc.
71900
In Commercial Distribution

  • 00801741080203 ()
71900

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Fill Tube
Medivance, Inc.
71800
In Commercial Distribution

  • 00801741080197 ()
71800

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Shunt Line
Medivance, Inc.
70904
In Commercial Distribution

  • 00801741080173 ()
70904

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® 5000
Medivance, Inc.
50000000L
In Commercial Distribution

  • 00801741080159 ()
50000000L

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
ARCTIC SUN 6000 115V B PWR LNR
Medivance, Inc.
60000000L
In Commercial Distribution

  • 00801741161520 ()
60000000L

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
ARCTIC SUN 6000 115V B PWR
Medivance, Inc.
60000000
In Commercial Distribution

  • 00801741161513 ()
60000000

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Simulator
Medivance, Inc.
77700
In Commercial Distribution

  • 00801741080531 ()
77700

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Service Kit Model 5000
Medivance, Inc.
77100
In Commercial Distribution

  • 00801741080487 ()
77100

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Patient Temperature Simulator
Medivance, Inc.
74800
In Commercial Distribution

  • 00801741080449 ()
74800

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

  • 00801741080418 ()
74100

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Cable Philips
Medivance, Inc.
73506
In Commercial Distribution

  • 00801741080333 ()
73506

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Cable Phono
Medivance, Inc.
73505
In Commercial Distribution

  • 00801741080326 ()
73505

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Cable Rusch
Medivance, Inc.
73504
In Commercial Distribution

  • 00801741080319 ()
73504

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Cable Nellcor
Medivance, Inc.
73502
In Commercial Distribution

  • 00801741080296 ()
73502

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Fluid Delivery Lines
Medivance, Inc.
73408
In Commercial Distribution

  • 00801741080272 ()
73408

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Fluid Delivery Lines
Medivance, Inc.
73407
In Commercial Distribution

  • 00801741080265 ()
73407

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Drain Bag
Medivance, Inc.
70905
In Commercial Distribution

  • 00801741080180 ()
70905

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® 5000
Medivance, Inc.
50000000
In Commercial Distribution

  • 00801741080142 ()
50000000

  • 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
Arctic Sun® 5000
Medivance, Inc.
50000000E
In Commercial Distribution

  • 00801741127755 ()
50000000E

  • 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 Stat Temperature Management System Fill Tube
Medivance, Inc.
72800
In Commercial Distribution

  • 00801741184314 ()
72800

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory kit for the thermoregulation System
BELMONT INSTRUMENT CORPORATION
200-00400
In Commercial Distribution

  • 07290012127984 ()
200-00400

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory kit for the thermoregulation System
BELMONT INSTRUMENT CORPORATION
200-00330
In Commercial Distribution

  • 07290012127977 ()
200-00330

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory kit for the thermoregulation System
BELMONT INSTRUMENT CORPORATION
200-00300
In Commercial Distribution

  • 07290012127946 ()
200-00300

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03548
In Commercial Distribution

  • 07290012127380 ()
  • 77290012127389 ()
  • 17290012127387 ()
500-03548

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03541
In Commercial Distribution

  • 07290012127373 ()
  • 17290012127370 ()
  • 77290012127372 ()
500-03541

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03536
In Commercial Distribution

  • 07290012127342 ()
  • 17290012127349 ()
  • 77290012127341 ()
500-03536

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03525
In Commercial Distribution

  • 07290012127328 ()
  • 17290012127325 ()
  • 77290012127327 ()
500-03525

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03125
In Commercial Distribution

  • 07290012127304 ()
  • 37290012127305 ()
500-03125

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 system. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03121
In Commercial Distribution

  • 07290012127298 ()
  • 37290012127299 ()
500-03121

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03118
In Commercial Distribution

  • 07290012127281 ()
  • 37290012127282 ()
500-03118

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03363
In Commercial Distribution

  • 07290012127274 ()
  • 27290012127278 ()
  • 57290012127279 ()
500-03363

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03160
In Commercial Distribution

  • 07290012127250 ()
  • 27290012127254 ()
  • 57290012127255 ()
500-03160

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool /Allon 2001 systems.
BELMONT INSTRUMENT CORPORATION
500-03148
In Commercial Distribution

  • 07290012127236 ()
  • 27290012127230 ()
  • 57290012127231 ()
500-03148

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03141
In Commercial Distribution

  • 07290012127229 ()
  • 27290012127223 ()
  • 57290012127224 ()
500-03141

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03136
In Commercial Distribution

  • 07290012127212 ()
  • 27290012127216 ()
  • 57290012127217 ()
500-03136

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the Allon 2001 systems. A body wrap connected to the thermoregulation system.
BELMONT INSTRUMENT CORPORATION
500-03131
In Commercial Distribution

  • 07290012127205 ()
  • 27290012127209 ()
  • 57290012127200 ()
500-03131

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03521
In Commercial Distribution

  • 07290012127199 ()
  • 17290012127196 ()
  • 77290012127198 ()
500-03521

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
500-03500
In Commercial Distribution

  • 07290012127175 ()
  • 17290012127172 ()
  • 77290012127174 ()
500-03500

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
CritiCool Mini Unit
BELMONT INSTRUMENT CORPORATION
200-00336
In Commercial Distribution

  • 07290107581301 ()
200-00336

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
No Description
BELMONT INSTRUMENT CORPORATION
200-00236
In Commercial Distribution

  • 07290107581110 ()
200-00236

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