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The EsoCool catheter is a thermal regulating device intended to connect to a Gentherm Blanketrol III Hyper-Hypothermia System to control the patient temperature.

The EsoCool Thermal Regulation Catheter is a dual lumen tube that is placed in the esophagus. The two lumens are connected to an external heater cooler to allow for circulation of cold or warm fluid in a closed loop system. Heater cooler control is used to modulate the fluid temperature and control of patient's temperature. The EsoCool catheter is made of polyurethane with barium sulfate for radiopacity. The EsoCool catheter is a single-use, disposable, non-implantable device with an intended duration of use of 24 hours or less.

Model # ECD05-A: The EnsoETM is a thermal regulating device, intended to: - · connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient's temperature, · allow enteral administration of fluids, and · provide gastric decompression and suctioning. Model # ECD06-A The EnsoETM is a thermal regulating device, intended to: · connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient's temperature, and · provide gastric decompression and suctioning.

The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to raise or maintain a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression, drainage, and enteral administration of fluids, thereby maintaining the functionality of the standard orogastric tube. Raising or maintaining patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the exchanger. A third central lumen connects to wall standard gastric decompression or, in some models, an enteral administration system to allow enteral administration of fluids. The device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with a duration of use of 72 hours or less.

Model # ECD03-A: The EnsoETM is a thermal regulating device, intended to: · connect to a Gaymar Medi-Therm III Conductive HyperHypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature, · allow enteral administration of fluids, · and provide gastric decompression and suctioning. Model # ECD04-A: The EnsoETM is a thermal regulating device, intended to: · connect to a Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System to control patient temperature. · allow enteral administration of fluids, · and provide gastric decompression and suctioning.

The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression, drainage, and enteral administration of fluids, thereby maintaining the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction to allow standard gastric decompression or an enteral administration system to allow enteral administration of fluids. The device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with a duration of use of 72 hours or less.

Model # ECD03-A: The EnsoETM is a thermal regulating device, intended to: • connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature, • allow enteral administration of fluids, • and provide gastric decompression and suctioning. Model # ECD04-A: The EnsoETM is a thermal regulating device, intended to: • connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature, • allow enteral administration of fluids, • and provide gastric decompression and suctioning.

The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression, drainage, and enteral administration of fluids, thereby maintaining the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the device to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction to allow standard gastric decompression or an enteral administration system to allow enteral administration of fluids. The device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 36 hours or less.

Model #ECD01-A: The EnsoETM is a thermal regulating device, intended to: · connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature, · and provide gastric decompression and suctioning. Model # ECD02-A The EnsoETM is a thermal regulating device, intended to: · connect to a Cincinnati Sub-Zero Blanketrol III Hyper-Hypothermia System to control patient temperature, · and provide gastric decompression and suctioning.

The EnsoETM is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to modulate a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage, thereby maintaining the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the EnsoETM to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction and is used for standard gastric decompression. The EnsoETM is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less.

The Esophageal Cooling Device is a thermal regulating device, intended to: - connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature, and - provide gastric decompression and suctioning.

The Esophageal Cooling Device is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to modulate a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage and maintain the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the Esophageal Cooling Device to an external heat exchanger. Two lumens connect to the exchanger. A third central lumen connects to wall suction and is used for standard gastric decompression. The Esophageal Cooling Device is made of standard medical-grade silicone. It is a single-use, disposable, non-implantable device with an intended duration of use of 36 hours or less.

Model #: ECD01-A: The Esophageal Cooling Device is a thermal regulating device, intended to: - connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and - provide gastric decompression and suctioning. Model #: ECD02-A: The Esophageal Cooling Device is a thermal regulating device, intended to: - connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature, and - provide gastric decompression and suctioning.

The Esophageal Cooling Device (ECD) is a multi-lumen silicone tube that is placed in the esophagus in a similar manner to a standard orogastric tube to modulate a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage and maintain the functionality of the standard orogastric tube. Modulation and control of patient temperature is achieved by connecting the ECD to an external heat exchanger. Two lumens connect to the external heat exchanger. A third central lumen connects to wall suction and is used for standard gastric decompression. The ECD is made of standard medical-grade silicone. It is a single-use, disposable, nonimplantable device.

The Esophageal Cooling Device is a thermal regulating device, intended to: - · connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and - · provide gastric decompression and suctioning.

The Esophageal Cooling Device (ECD) is a silicone tube with three lumens that is placed in the esophagus (Figure 1). The intended function of the device is to control a patient's temperature. while simultaneously maintaining access to the stomach to allow gastric decompression and drainage. Modulation and control of patient temperature is intended to be achieved by connecting the ECD to an external heat exchanger and circulating temperaturecontrolled fluid (distilled water). Two lumens (the cooling lumens) connect to the external heat exchanger and are in contact with the esophageal tissues. A third central lumen connects to wall suction and is used for standard gastric decompression. A web supports the inner gastric lumen and separates the cooling lumens. The ECD is made of standard medical-grade silicone. It is a single-use, disposable, nonimplantable device with a stated intended duration of use of 36 hours or less. The ECD is intended to be used in conjunction with the Gaymar Medi-Therm III Conductive Hyper/Hypothermia System (cleared under K100585) with the following operating specifications: - · Dead Head Pressure: Maximum 9 psi (62 kPa) - Flow: Minimum 16 gallons/h (60.6 L/hr) - · Water Temperature Control Range: 4°C 42°C The Gaymar System supplies temperature-controlled water through a connector hose to the ECD. An accessory probe interfaces between the Gaymar System and the patient to sense patient temperature, which is displayed on the Gavmar System's control panel. The Gaymar device controls water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control and includes a circulating pump, heater, and refrigeration system.