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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 THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
Zoll Circulation, Inc.
NA
In Commercial Distribution

  • 00849111075565 ()


  • Intravascular core temperature regulation system
The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
Zoll Circulation, Inc.
NA
In Commercial Distribution

  • 00849111075558 ()


  • Intravascular core temperature regulation system
The Solex Catheter is a 9.3 F, 26 cm, triple infusion lumen catheter designed for placement in the superior vena cava from an insertion site in the jugular vein.
Zoll Circulation, Inc.
SL-2593CO
In Commercial Distribution

  • 00849111075541 ()

  • Length: 26 Centimeter
  • Catheter Gauge: 9.3 French
8700-0793-14

  • Intravascular core temperature regulation system catheter
The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
Zoll Circulation, Inc.
IC-4593CO
In Commercial Distribution

  • 00849111075534 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 9.3 French
8700-0783-14

  • Intravascular core temperature regulation system catheter
The Icy® Heat Exchange Catheter is a sterile, single use flexible 9.3 F catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
Zoll Circulation, Inc.
IC-3893CO
In Commercial Distribution

  • 00849111075527 ()

  • Length: 38 Centimeter
  • Catheter Gauge: 9.3 French
8700-0782-14

  • Intravascular core temperature regulation system catheter
The Cool Line® Heat Exchange Catheter is a 9.3 Fr, 22 cm, triple infusion lumen catheter designed for placement in the central venous circulation from an insertion site in the jugular, subclavian, or femoral veins.
Zoll Circulation, Inc.
CL-2295CO
In Commercial Distribution

  • 00849111075510 ()

  • Length: 22 Centimeter
  • Catheter Gauge: 9.3 French
8700-0781-14

  • Intravascular core temperature regulation system catheter
The Quattro Heat Exchange Heat Catheter is a 9.3 Fr, 45 cm, triple infusion lumen catheter designed for placement in the inferior vena cava from an insertion site in the femoral vein.
Zoll Circulation, Inc.
IC-4593
In Commercial Distribution

  • 00849111075503 ()

  • Length: 45 Centimeter
  • Catheter Gauge: 9.3 French
8700-0791-01

  • Intravascular core temperature regulation system catheter
The InnerCool RTx Circulating Cassette is part of the InnerCool RTx Endovascular Cooling System. It cools the heat-transfer fluid that circulates through the Cassette and Catheters.
Zoll Circulation, Inc.
NA
In Commercial Distribution

  • 00849111075459 ()
8700-000831-01

  • Intravascular core temperature regulation system
The InnerCool RTx Circulating Cassette is part of the InnerCool RTx Endovascular Cooling System. It cools the heat-transfer fluid that circulates through the Cassette and Catheters.
Zoll Circulation, Inc.
NA
In Commercial Distribution

  • 00849111075442 ()
8700-000830-01

  • Intravascular core temperature regulation system
An endovascular catheter having a heat exchange element at the distal end, through which a thermal transfer fluid is circulated to cool or warm the blood, and which has 10.7 Fr diameter.
Zoll Circulation, Inc.
NA
In Commercial Distribution

  • 00849111075435 ()

  • Catheter Gauge: 10.7 French
8700-000829-01

  • Intravascular core temperature regulation system catheter
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