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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The CardioQuip Refrigeration Module is a module of the CardioQuip Modular Cooler-Heater (MCH) which creates an ice block in the tank in order to lower the temperature of the water. The MCH is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-10RMS
In Commercial Distribution

  • 00860000846127 ()


  • Cardiopulmonary bypass system heating/cooling unit
The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-1000(m)
In Commercial Distribution

  • 00860000846110 ()


  • Cardiopulmonary bypass system heating/cooling unit
The CardioQuip Modular Cooler-Heater (MCH) is indicated to supply temperature-controlled water to heat exchange devices (e.g.; CPB Heat Exchangers, Cardioplegia Heat Exchangers, and thermal regulating system blankets) to help control a patient's temperature during cardiopulmonary bypass procedures lasting not longer than six hours.
CARDIOQUIP, LLC
MCH-1000(i)
In Commercial Distribution

  • 00860000846103 ()


  • Cardiopulmonary bypass system heating/cooling unit
CoolFlow SM.03.DTX Heat Transfer Fluid 1.5L
SPECTRUM MEDICAL LIMITED
SM.03.DTX
In Commercial Distribution

  • 05060434423757 ()
51-000089-00

  • Cardiopulmonary bypass system heating/cooling unit
Hose Kit - 9.5mm Bore 4.5m (kit of 2)
SPECTRUM MEDICAL LIMITED
52-000047-00
In Commercial Distribution

  • 05060434422491 ()
52-000047-00

  • Cardiopulmonary bypass system heating/cooling unit
Hose Kit - 9.5mm Bore 2.5m (kit of 2)
SPECTRUM MEDICAL LIMITED
52-000046-00
In Commercial Distribution

  • 05060434422484 ()
52-000046-00

  • Cardiopulmonary bypass system heating/cooling unit
Hose Kit - 12.5mm Bore 2.5m (kit of 2)
SPECTRUM MEDICAL LIMITED
52-000044-00
In Commercial Distribution

  • 05060434422460 ()
52-000044-00

  • Cardiopulmonary bypass system heating/cooling unit
Quantum Heater Cooler
SPECTRUM MEDICAL LIMITED
QHC1
In Commercial Distribution

  • 05060434420961 ()
51-000058-00

  • Cardiopulmonary bypass system heating/cooling unit
Hose Kit - 12.5mm Bore 4.5m (kit of 2)
SPECTRUM MEDICAL LIMITED
52-000045-00
In Commercial Distribution

  • 05060434422477 ()
52-000045-00

  • Cardiopulmonary bypass system heating/cooling unit
No Description
LivaNova Deutschland GmbH
Water Tubing 25m
In Commercial Distribution

  • 04033817901549 ()


  • Cardiopulmonary bypass system heating/cooling unit
No Description
LivaNova Deutschland GmbH
3T 240V ~ / 60Hz
In Commercial Distribution

  • 04033817901112 ()


  • Cardiopulmonary bypass system heating/cooling unit
No Description
LivaNova Deutschland GmbH
3T 120V ~ / 60Hz
In Commercial Distribution

  • 04033817900528 ()


  • Cardiopulmonary bypass system heating/cooling unit
No Description
LivaNova Deutschland GmbH
3T 208V ~ / 60Hz
In Commercial Distribution

  • 04033817900511 ()


  • Cardiopulmonary bypass system heating/cooling unit
Hemotherm® Dual Reservoir Cooler/Heater (115V, 50Hz)
Gentherm Medical, LLC
400CE
In Commercial Distribution

  • 10613031860221 ()

  • Height: 32 Inch
  • Depth: 22 Inch
  • Width: 22 Inch
  • Weight: 198 Pound
  • Area/Surface Area: 484 Square inch
86022

  • Cardiopulmonary bypass system heating/cooling unit
Water fitting, quick-connect for use with oxygenation systems, straight
Terumo Cardiovascular Systems Corporation
131086
In Commercial Distribution

  • 00886799001769 ()
131086

  • Cardiopulmonary bypass system heating/cooling unit
Water fitting, quick-connect for use with oxygenation systems, right angle
Terumo Cardiovascular Systems Corporation
131078
In Commercial Distribution

  • 00886799001752 ()
131078

  • Cardiopulmonary bypass system heating/cooling unit
Water fitting, quick-connect for use with myocardial protection systems
Terumo Cardiovascular Systems Corporation
9439
In Commercial Distribution

  • 00886799001745 ()
9439

  • Cardiopulmonary bypass system heating/cooling unit
HX2 Temperature Control System Accessory Hose Kit
Terumo Cardiovascular Systems Corporation
809883
In Commercial Distribution

  • 00886799000908 ()
809883

  • Cardiopulmonary bypass system heating/cooling unit
TCM II Remote Control Module with Temperature Displays
Terumo Cardiovascular Systems Corporation
15746
In Commercial Distribution

  • 00886799000168 ()
15746

  • Cardiopulmonary bypass system heating/cooling unit
Temperature Probe Module For TCM II System
Terumo Cardiovascular Systems Corporation
15745
In Commercial Distribution

  • 00886799000151 ()
15745

  • Cardiopulmonary bypass system heating/cooling unit
CATHETER CF6-8-100 CLOSUREFAST
MEDTRONIC, INC.
CF6-8-100
In Commercial Distribution

  • 00763000552176 ()

  • Insertable length: 100 cm
  • Introducer sheath: 6 Fr
  • Heating element length: 8 cm
  • Minimum ID size: 2.0 mm
  • Heating element diameter: 2.0 mm


  • Peripheral vascular electrocautery catheter, single-use
CATHETER CF6-8-60 CLOSUREFAST
MEDTRONIC, INC.
CF6-8-60
In Commercial Distribution

  • 00763000552169 ()

  • Heating element diameter: 2.0 mm
  • Introducer sheath: 6 Fr
  • Insertable length: 60 cm
  • Minimum ID size: 2.0 mm
  • Heating element length: 8 cm


  • Peripheral vascular electrocautery catheter, single-use
No Description
W.O.M. World of Medicine GmbH
Z1415-01
In Commercial Distribution

  • 04056702000080 ()


  • Laparoscopic insufflator
3100A DISPOSABLES SHIP KIT (RIGID CIRCUIT)
VYAIRE MEDICAL, INC.
770630-101
Not in Commercial Distribution

  • 10190752155398 ()
770630-101

  • Ventilator breathing circuit, single-use
  • Respiratory gas heating wire, adult
3100A DISPOSABLES SHIP KIT (RIGID CIRCUIT)
VYAIRE MEDICAL, INC.
770630-101
In Commercial Distribution

  • 10190752201576 ()
770630-101

  • Ventilator breathing circuit, single-use
  • Respiratory gas heating wire, adult
set contains Caps Sticks A1, A2, A3, uni, Caps Warmer
VOCO GmbH
6063
In Commercial Distribution

  • E22160631 ()
  • E2216063 ()


  • Dental composite resin
  • Anaesthesia warmer
set contains Caps Sticks A1, A2, A3, uni, VisCalor Dispenser
VOCO GmbH
6062
In Commercial Distribution

  • E22160621 ()
  • E2216062 ()


  • Anaesthesia warmer
  • Dental composite resin
LED light source, red
STRYKER CORPORATION
PRLS-100
In Commercial Distribution

  • 00857326005581 ()
  • 10857326005588 ()


  • Endoscopic light source unit, battery-powered
No Description
COGENTIX MEDICAL, INC.
BLS-1000
In Commercial Distribution

  • 00874485000318 ()
07-3050

  • Endoscopic light source unit, battery-powered
LED Portable Light Source
OPTIM LLC
F0063873L1
In Commercial Distribution

  • 00858119004101 ()


  • Endoscopic light source unit, battery-powered
The Genesis RapidWeld II STW, model GRW-430-02, is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430-02
In Commercial Distribution

  • 00866305000264 ()

  • Length: 33 Centimeter
  • Height: 9.9 Centimeter
  • Width: 14.2 Centimeter
  • Weight: 2.5 Kilogram
480-RW-2607-02

  • Laboratory tubing welder
The TCD B40 is a bench top, portable device intended for use by appropriately trained and qualified personnel in hospital/laboratory/clinical settings for the purpose of making sterile connections of 3.9 mm to 4.5 mm PVC tubing in blood processing applications.
GENESIS BPS LLC
TCD B40
In Commercial Distribution

  • 00866305000219 ()

  • Weight: 1.6 Kilogram
  • Width: 9.1 Centimeter
  • Length: 27.2 Centimeter
  • Height: 5.9 Centimeter
480-B40-00-1245

  • Laboratory tubing welder
The Genesis Rapid Weld STW is a medical device used in laboratories, designed for the purpose of making sterile connections in PVC tubing in blood processing applications. The device enables fluid transfer while maintaining a closed system without the need for a consumable (disposable wafer).
GENESIS BPS LLC
GRW-430
In Commercial Distribution

  • 00866305000202 ()

  • Weight: 2.5 Kilogram
  • Width: 14.2 Centimeter
  • Height: 9.9 Centimeter
  • Length: 33 Centimeter
480-RW-2607-00

  • Laboratory tubing welder
Compact handheld light source (battery operated)
Firefly Global
ES201
In Commercial Distribution

  • 00851289007002 ()


  • Endoscopic light source unit, battery-powered
No Description
MACHIDA ENDOSCOPE CO.,LTD.
RLED-30
In Commercial Distribution

  • 04580137732617 ()


  • Endoscopic light source unit, battery-powered
LIGHTSOURCE 3W SSL-3XSA
PENTAX OF AMERICA, INC.
1111-1917
In Commercial Distribution

  • 04961333231270 ()


  • Endoscopic light source unit, battery-powered
PENTAX LED Light Source BS-LL Series
HOYA CORPORATION
BS-LL1
In Commercial Distribution

  • 04961333227259 ()
  • 04961333228942 ()


  • Endoscopic light source unit, battery-powered
O-Ring Set For BS-LL1 OF-B204
HOYA CORPORATION
OF-B204
Not in Commercial Distribution

  • 04961333195077 ()


  • Endoscopic light source unit, battery-powered
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-525
In Commercial Distribution

  • 84953170063356 ()
  • 04953170437984 ()
N6175601

  • Endoscopic light source unit, battery-powered
No Description
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-524
In Commercial Distribution

  • 04953170434419 ()
5696201

  • Endoscopic light source unit, battery-powered
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