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, 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
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
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
Omnilux Men's Facemask Device (Red & NIR).
I-SMART DEVELOPMENTS LIMITED
TN2227
In Commercial Distribution

  • 05060534510524 ()


  • Cosmetic red-light phototherapy system, home-use
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fine lines and wrinkles and increase in circulation within the perioral region.
Shenzhen Kaiyan Medical Equipment Co,. Ltd
ZC-05
In Commercial Distribution

  • 00655729008426 ()


  • Cosmetic red-light phototherapy system, home-use
No Description
B&M SRL MARKETING NEL BENESSERE
T-SHAPE 2
In Commercial Distribution

  • 08053782383283 ()


  • Multi-modality skin/body contouring system
STATIONARY HI-BOY WHIRLPOOL, -EG07
Whitehall Manufacturing Co
H-105-SL-0003
In Commercial Distribution

  • 00645724004509 ()
H105SL0003

  • Hydrotherapy bath/tank
  • Hydro-massage turbine
MOBILE EXTREMITY WHIRLPOOL W/UK PWR CORD
Whitehall Manufacturing Co
E-22-M-0009
In Commercial Distribution

  • 00645724004493 ()
E22M0009

  • Hydrotherapy bath/tank
  • Hydro-massage turbine
TURBINE, 220V SCHUKO CORD
Whitehall Manufacturing Co
AW-606B-CORD1
In Commercial Distribution

  • 00645724004295 ()
AW606BCORD1

  • Hydrotherapy bath/tank
  • Hydro-massage turbine
STATIONARY EXTREMITY WHIRLPOOL
Whitehall Manufacturing Co
E-36-S
In Commercial Distribution

  • 00645724004271 ()
E36S

  • Hydrotherapy bath/tank
  • Hydro-massage turbine
MOBILE SPORTS WHIRLPOOL BATH, RAL 5011
Whitehall Manufacturing Co
S-90-M-0005
In Commercial Distribution

  • 00645724004264 ()
S90M0005

  • Hydrotherapy bath/tank
  • Hydro-massage turbine
S-110-SL, EG22 MATTE BLACK
Whitehall Manufacturing Co
S-110-SL-0005
In Commercial Distribution

  • 00645724004257 ()
S110SL0005

  • Hydrotherapy bath/tank
  • Hydro-massage turbine
SLANT BACK WHIRLPOOL w/-SDO-GFI-120V
Whitehall Manufacturing Co
SB-100-S-0003
In Commercial Distribution

  • 00645724003519 ()
SB-100-S-0003

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
100-GAL 115V/60HZ SLANT STNARY WHIRLPOOL
Whitehall Manufacturing Co
SB-100-S-0002
In Commercial Distribution

  • 00645724003502 ()
SB-100-S-0002

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
100-GAL 115V/60HZ SLANT MOBILE, W/ GFI
Whitehall Manufacturing Co
SB-100-M-0004
In Commercial Distribution

  • 00645724003496 ()
SB-100-M-0004

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
SB-100-M,220V,50Hz, European power cord
Whitehall Manufacturing Co
SB-100-M-0003
In Commercial Distribution

  • 00645724003489 ()
SB-100-M-0003

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
100-GAL 115V/60HZ SLANT MOBILE WHIRLPOOL
Whitehall Manufacturing Co
SB-100-M-0002
In Commercial Distribution

  • 00645724003472 ()
SB-100-M-0002

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
S-90-SL, STATIONARY SPORTS WHIRLPOOL
Whitehall Manufacturing Co
S-90-SL-0001
In Commercial Distribution

  • 00645724003465 ()
S-90-SL-0001

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
STATIONARY SPORTS WHIRPOOL, BLUE
Whitehall Manufacturing Co
S-90-S-0004
In Commercial Distribution

  • 00645724003458 ()
S-90-S-0004

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
STATIONARY SPORTS WHIRLPOOL BATH
Whitehall Manufacturing Co
S-90-S-0003
In Commercial Distribution

  • 00645724003441 ()
S-90-S-0003

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
STATIONARY SPORTS WHIRLPOOL Less Turbine
Whitehall Manufacturing Co
S-90-S-0002
In Commercial Distribution

  • 00645724003434 ()
S-90-S-0002

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
STATIONARY SPORTS WHIRLPOOL
Whitehall Manufacturing Co
S-90-S-0001
In Commercial Distribution

  • 00645724003427 ()
S-90-S-0001

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
S-90-M, MAYO HIGH SCHOOL LOGO
Whitehall Manufacturing Co
S-90-M-0004
In Commercial Distribution

  • 00645724003410 ()
S-90-M-0004

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
MOBILE SPORTS WHIRLPOOL BATH
Whitehall Manufacturing Co
S-90-M-0003
In Commercial Distribution

  • 00645724003403 ()
S-90-M-0003

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
MOBILE SPORTS WHIRLPOOL LESS TURBINE
Whitehall Manufacturing Co
S-90-M-0002
In Commercial Distribution

  • 00645724003397 ()
S-90-M-0002

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
MOBILE SPORTS WHIRLPOOL
Whitehall Manufacturing Co
S-90-M-0001
In Commercial Distribution

  • 00645724003380 ()
S-90-M-0001

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
STATIONARY SPORTS WHIRLPOOL W/LEGS
Whitehall Manufacturing Co
S-85-SL-0001
In Commercial Distribution

  • 00645724003373 ()
S-85-SL-0001

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
STA. SPORTS WHIRLPOOL BATH LESS TURBINE
Whitehall Manufacturing Co
S-85-S-0002
In Commercial Distribution

  • 00645724003366 ()
S-85-S-0002

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
STATIONARY SPORTS WHIRLPOOL
Whitehall Manufacturing Co
S-85-S-0001
In Commercial Distribution

  • 00645724003359 ()
S-85-S-0001

  • Hydro-massage turbine
  • Hydrotherapy bath/tank
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