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
500-03136
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
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
Accessory for the CritiCool system. A body wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Pediatric 91-104cm (single)
Not in Commercial Distribution

  • 07290107580663 ()
  • 17290107580660 ()
500-T3536

  • 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 79-91cm (single)
Not in Commercial Distribution

  • 07290107580656 ()
  • 17290107580653 ()
500-T3531

  • 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
Infant 7-21Kg (single)
Not in Commercial Distribution

  • 07290107580649 ()
  • 17290107580646 ()
500-T3525

  • 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
Infant 4-7Kg (single)
Not in Commercial Distribution

  • 07290107580632 ()
  • 17290107580639 ()
500-T3521

  • 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
Infant (single)
In Commercial Distribution

  • 07290107580625 ()
  • 17290107580622 ()
500-T3518

  • 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
Adult (single)
Not in Commercial Distribution

  • 07290107580618 ()
  • 17290107580615 ()
500-T3500

  • 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
X-Large Pediatric over 135cm (single)
Not in Commercial Distribution

  • 77290107580266 ()
  • 07290107580267 ()
PED-X2001

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

  • 77290107580242 ()
  • 07290107580243 ()
PED-X1001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory connected to the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03541
Not in Commercial Distribution

  • 07290107580212 ()
  • 77290107580211 ()
  • 17290107580080 ()
PED-L2001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system.
BELMONT INSTRUMENT CORPORATION
500-03536
Not in Commercial Distribution

  • 07290107580199 ()
  • 77290107580198 ()
PED-L1001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
No Description
BELMONT INSTRUMENT CORPORATION
500-03531
Not in Commercial Distribution

  • 07290107580168 ()
  • 77290107580167 ()
PED-M2001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory for the CritiCool system. Abody wrap connected to the CritiCool.
BELMONT INSTRUMENT CORPORATION
Medium1 Pediatric 7-11 kg (single)
Not in Commercial Distribution

  • 07290107580144 ()
  • 77290107580143 ()
PED-M1001

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

  • 07290107580113 ()
  • 17290107580134 ()
  • 77290107580112 ()
PED-S2001

  • 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 up to 4K (single)
Not in Commercial Distribution

  • 07290107580090 ()
  • 77290107580099 ()
PED-S1001

  • External circulating-fluid core temperature regulation system control unit, heating/cooling
Accessory kit for Allon 2001 and CritiCool.
BELMONT INSTRUMENT CORPORATION
200-00420
In Commercial Distribution

  • 07290107580007 ()
200-00420

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

  • 00801741127755 ()
50000000E

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

  • 00801741080470 ()
75300

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