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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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.
BELMONT INSTRUMENT CORPORATION
500-03518
In Commercial Distribution

  • 07290012127182 ()
  • 17290012127189 ()
  • 77290012127181 ()
500-03518

  • 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
Accessory kit for the thermoregulation System
BELMONT INSTRUMENT CORPORATION
200-00410
In Commercial Distribution

  • 07290012127991 ()
200-00410

  • 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
200-00310
In Commercial Distribution

  • 07290012127953 ()
200-00310

  • 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 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 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
No Description
BELMONT INSTRUMENT CORPORATION
500-03166
In Commercial Distribution

  • 07290012127267 ()
  • 27290012127261 ()
  • 57290012127262 ()
500-03166

  • 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
500-03153
In Commercial Distribution

  • 07290012127243 ()
  • 27290012127247 ()
  • 57290012127248 ()
500-03153

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

  • 00801741080548 ()
73407L

  • 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® 5000 Control Panel Screen Protector
Medivance, Inc.
75300
In Commercial Distribution

  • 00801741080470 ()
75300

  • 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, Cleaning Solution
Medivance, Inc.
73905
In Commercial Distribution

  • 00801741080401 ()
73905

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Out Cable Philips
Medivance, Inc.
73556
In Commercial Distribution

  • 00801741080388 ()
73556

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System Assy, Cable, Temp Out, Phono Plug GE
Medivance, Inc.
73555
In Commercial Distribution

  • 00801741080371 ()
73555

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temperature Out Cable Rusch
Medivance, Inc.
73554
In Commercial Distribution

  • 00801741080364 ()
73554

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temp Out Cable, Bard/Lemo Connector
Medivance, Inc.
73553
In Commercial Distribution

  • 00801741080357 ()
73553

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Arctic Sun® Temperature Management System, Temp Out Cable, Simms/Lemo Connector
Medivance, Inc.
73552
In Commercial Distribution

  • 00801741080340 ()
73552

  • 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 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, 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, 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 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, 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, 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, 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, Drain Bag
Medivance, Inc.
70905
In Commercial Distribution

  • 00801741080180 ()
70905

  • 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® 5000
Medivance, Inc.
50000000
In Commercial Distribution

  • 00801741080142 ()
50000000

  • 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
No Description
BELMONT INSTRUMENT CORPORATION
200-00263
In Commercial Distribution

  • 07290107581103 ()
200-00263

  • 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
Pediatric 122-135cm (single )
Not in Commercial Distribution

  • 07290107580687 ()
  • 17290107580684 ()
500-T3548

  • 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
Pediatric 104-122cm (single)
Not in Commercial Distribution

  • 07290107580670 ()
  • 17290107580677 ()
500-T3541

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