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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3M™ Bair Hugger™ Warming Blanket 11101, Outpatient, 10/Case
3M COMPANY
11101
In Commercial Distribution

  • 00707387790035 ()
  • 50707387790030 ()
11101

  • Circulating-air whole-body heating/cooling system pad, single-use, sterile
3M™ Bair Hugger™ Sterile Cardiac Access Blanket, 5 per case, 64500
3M COMPANY
64500
In Commercial Distribution

  • 50707387775143 ()
  • 00707387775148 ()
64500

  • Circulating-air whole-body heating/cooling system pad, single-use, sterile
3M™ Bair Hugger™ Sterile Full Access Underbody Blanket, 5 per case, 63700
3M COMPANY
63700
In Commercial Distribution

  • 50707387775136 ()
  • 00707387775131 ()
63700

  • Circulating-air whole-body heating/cooling system pad, single-use, sterile
3M™ Bair Hugger™ Sterile Cardiac Blanket, 5 per case, 63000
3M COMPANY
63000
In Commercial Distribution

  • 50707387775112 ()
  • 00707387775117 ()
63000

  • Circulating-air whole-body heating/cooling system pad, single-use, sterile
Thermal Regulating System
Gentherm Medical, LLC
542
In Commercial Distribution

  • 20613031825425 ()
  • 10613031825428 ()

  • Width: 50.0 Inch
  • Length: 72.0 Inch
  • Weight: 0.7 Pound
82542

  • Circulating-air whole-body heating/cooling system pad, single-use, sterile
3M™ Bair Hugger® Underbody Blanket, Full Access, Sterile, 10 Per Case 63700
3M COMPANY
63700
In Commercial Distribution

  • 30608223637006 ()
  • 00608223637005 ()
63700

  • Circulating-air whole-body heating/cooling system pad, single-use, sterile
HotRock is a self-heated foam roller used to relieve minor ache and pains. It is basically a heating pad built into a foam roller.
MEDROCK, INC
HR-001
In Commercial Distribution

  • 00860000412711 ()


  • External manual massager, clinical
Pain Relief, Multi-function Physiotherapy table, thermal infrared therapeutic heating, Therapeutic manual and electric massage, muscle relaxation, increase circulation.
MIGUN LIFE CO., LTD
HY7000UM
In Commercial Distribution

  • B556HY7000UM0 ()


  • Freestanding electric massager
  • Musculoskeletal infrared phototherapy unit, non-wearable
  • Traction table, line-powered
Low level Light System (red light LED and infrared LED) that applies 635nm light and 880nm light for Aesthtic use and for pain indications.
KBL GmbH
R11-s-2848r1-1188i1 UP 12
In Commercial Distribution

  • 04260489020425 ()


  • Red/infrared light phototherapy unit
The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
CHALICE MEDICAL LIMITED
CME40009
In Commercial Distribution

  • 05060912587483 ()
  • 15060912587480 ()
  • 05060491619810 ()
CME40009

  • Extracorporeal membrane oxygenation system circuit
HUMIDIFIED INSUFFLATION KIT
FISHER & PAYKEL HEALTHCARE LIMITED
ST520
In Commercial Distribution

  • 09420012433985 ()
  • 09420012433978 ()
ST520

  • Insufflation gas conditioning tubing set
HUMIDIFIER SH870 115V US
FISHER & PAYKEL HEALTHCARE LIMITED
SH870JHU
In Commercial Distribution

  • 09420012433060 ()
SH870JHU

  • Insufflation gas conditioning system control unit
This is Box 2 of 3 for the Spartan RX CYP2C19 Platform. It contains the Spartan RX Netbook (01003214) and the Spartan RX Printer (01003438).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420071 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
This is Box 1 of 3 of the Spartan RX CYP2C19 Platform. It contains the Spartan RX Analyzer (01004777) and the Spartan RX Barcode Scanner (01003359).
Spartan Bioscience Inc
01004985
In Commercial Distribution

  • 00628055420064 ()
01004985

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
The Spartan RX Sample Transport System supplied with the Spartan RX CYP2C19 System. It includes: Carrying bag (01003374), Cold block (01003372), and Insulated box (01003373).
Spartan Bioscience Inc
01003374, 01003372, and 01003373
In Commercial Distribution

  • 00628055420057 ()
01003374, 01003372, and 01003373

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Barcode Scanner supplied with the Spartan RX CYP2C19 System.
Spartan Bioscience Inc
01003359
In Commercial Distribution

  • 00628055420040 ()
01003359

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Printer supplied with the Spartan RX CYP2C19 System
Spartan Bioscience Inc
01003438
In Commercial Distribution

  • 00628055420033 ()
01003438

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Netbook supplied with the Spartan RX CYP2C19 System.
Spartan Bioscience Inc
01003214
In Commercial Distribution

  • 00628055420026 ()
01003214

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Spartan RX Analyzer
Spartan Bioscience Inc
01004777
In Commercial Distribution

  • 00628055420019 ()
01004777

  • Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
The CMO8 Adult PMP Oxygenator with Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
CHALICE MEDICAL LIMITED
CME40009
Not in Commercial Distribution

  • 15060491619817 ()
  • 05060491619810 ()
CME40009

  • Extracorporeal membrane oxygenation system circuit
The Adult Tubing Pack with Paragon Adult Maxi PMP Oxygenator is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
CHALICE MEDICAL LIMITED
CME40004
In Commercial Distribution

  • 15060491614126 ()
  • 05060491614129 ()
CME40004

  • Extracorporeal membrane oxygenation system circuit
The AMSCO Pass-Thru OR Consolidated Warming Cabinet with 120V, 24-inch wide, dual compartment, solid doors, 18-inch depth, Standard Control is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
CB4721003001
In Commercial Distribution

  • 00724995154189 ()
CB4721003001

  • Multi-purpose warming cabinet, recessed
The AMSCO Warming Cabinet Premium Solid Dual 24-inch 120V Mobile Electronic Door Locks Electronic Data Recording is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ04012433113
In Commercial Distribution

  • 00724995154134 ()
DJ04012433113

  • Multi-purpose warming cabinet, mobile
The AMSCO Warming Cabinet Standard Glass Dual 24-inch 120V Mobile, is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ06012433111
In Commercial Distribution

  • 00724995154042 ()
DJ06012433111

  • Multi-purpose warming cabinet, mobile
The AMSCO Warming Cabinet Premium Glass Dual 24-inch 120V Mobile Electronic Door Locks Electronic Data Recording is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ06012433113
In Commercial Distribution

  • 00724995154028 ()
DJ06012433113

  • Multi-purpose warming cabinet, mobile
The AMSCO Glass Door Mid-Size Compartment Premium Cabinet, Mobile Base with Electronic Door Locks and Electronic Data Recording, 120V, is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ06012412313
In Commercial Distribution

  • 00724995154004 ()
DJ06012412313

  • Multi-purpose warming cabinet, mobile
The AMSCO Warming Cabinet Standard Solid Dual 24-inch 120V Mobile is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable Level.
STERIS CORPORATION
DJ04012433111
In Commercial Distribution

  • 00724995153960 ()
DJ04012433111

  • Multi-purpose warming cabinet, mobile
Warming Cabinet Standard Glass Dual 24-inch Mobile is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable level.
STERIS CORPORATION
Warming Cabinet
In Commercial Distribution

  • 00724995153816 ()
DJ06014433111

  • Multi-purpose warming cabinet, mobile
6th Generation Mid-size Single Compartment Mobile Warming Cabinet is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable level.
STERIS CORPORATION
Warming Cabinet
In Commercial Distribution

  • 00724995153779 ()
DJ06014412313

  • Multi-purpose warming cabinet, mobile
System used to regulate temperature and oxygen content of sterile water for a procedure.
FOCUS SURGERY INC
102-17000-0007
In Commercial Distribution

  • 00868108000274 ()


  • Ultrasonic hyperthermia system
A combination kit consisting 1 Water Path Kit and 1 Sonablate Probe Tip Kit
FOCUS SURGERY INC
403-02200-0014
In Commercial Distribution

  • 00868108000267 ()


  • Ultrasonic hyperthermia system
Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy.
FOCUS SURGERY INC
202-17000-0012
In Commercial Distribution

  • 00868108000229 ()


  • Ultrasonic hyperthermia system
Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions.
FOCUS SURGERY INC
102-17000-0009
In Commercial Distribution

  • 00868108000212 ()


  • Ultrasonic hyperthermia system
No Description
Estill Medical Technologies, Inc.
TA-UPC
In Commercial Distribution

  • 00861816000390 ()
  • 00861816000345 ()
  • 10861816000342 ()


  • Convection blood/fluid warmer
The TA-UB1 Thermal Angel Ultra Battery is a rechargeable 12V LifePO4 (LFP) battery designed to power the Thermal Angel TA-200.
Estill Medical Technologies, Inc.
TA-UB1
In Commercial Distribution

  • 00861816000338 ()
  • 00861816000352 ()


  • Convection blood/fluid warmer
A blood warmer and IV fluid warmer, the Thermal Angel is a battery-powered disposable, lightweight easy to use portable blood and IV fluid warming device. The Thermal Angel blood warmer works in your environmen
Estill Medical Technologies, Inc.
TA-200
In Commercial Distribution

  • 00861816000314 ()
  • 00861816000307 ()
  • 00861816000321 ()


  • Convection blood/fluid warmer
Warming Cabinet Pass Through 30"W x 74 1/2"H x 27 1/2"D w/(2) Glass Doors w/(2) Glass Rear Doors w/(3) Adj Shelves
Blickman Industries, LLC
7924TPTGG
In Commercial Distribution

  • 00850038811259 ()
14B7924378

  • Multi-purpose warming cabinet, recessed
Warming Cabinet Pass Through 30"W x 35 1/2"H x 26 1/2"D w/(2) Glass Doors w/(2) Adj Shelves
Blickman Industries, LLC
7922TPTGG
In Commercial Distribution

  • 00850038811242 ()
14B7922279

  • Multi-purpose warming cabinet, recessed
Warming Cabinet 30"W x 60"H x 20 5/8"D w/(1) Solid Door w/(3) Adj Shelves 220V
Blickman Industries, LLC
SW30TS2
In Commercial Distribution

  • 00850038811235 ()
14BSW30220

  • Multi-purpose warming cabinet, recessed
Warming Cabinet 30"W x 60"H x 20 5/8"D w/(1) Glass Door w/(3) Adj Shelves 220V
Blickman Industries, LLC
SW30TG2
In Commercial Distribution

  • 00850038811228 ()
14BSW30221

  • Multi-purpose warming cabinet, recessed
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