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The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for six hours or less with a maximum blood flow rate of 1.5 liters/minute. PATIENT POPULATION: Infants.

AMG PMP INFANT is an oxygenator used to exchange gases between blood and gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery. It is composed by PMP (Polymethylpentene) hollow fiber membrane with an integrated heat exchanger. It is provided together with the accessories that are the gas line and the convenience kit. Oxygenator module, AMG PMP INFANT consist of three path, blood path, water path. These three paths, thanks to the particular configuration, allow the blood temperature control and gas exchange. The device center consists stainless steel tubes that allow the control of the temperature of the blood. The exchange of heat is between the water (with controlled temperature) that flows outside of steel tubes and the blood that flows inside the steel tubes. The device center is surrounded by an outer compartment that contains a microporous membrane of Polymethylpentene (PMP) consisting of capillary allow fibers that allows gas exchange. The air form the gas mixer rich in O2 follows the gas path: is insufflated through the gas inlet port on the top of the device, goes through microporous PMP fibers and exit from gas escape port, at the same time blood go outside the microporous fibers. The design of heat exchangers for cooling and rewarming blood in the oxygenator centers allows making a biologically inert surface capable of achieving the desired rate of heat exchange, without producing any localized overheating of the blood.

The device is indicated for patients who undergo cardiopulmonary bypass surgery requiring extracorporeal circulation for six hours or less with a maximum blood flow rate of 4 liters/minute. PATIENT POPULATION: Pediatric / small adults.

AMG PMP PEDIATRC is an oxygenator used to exchange gases between blood and gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery. It is composed by PMP (Polymethylpentene) hollow fiber membrane with an integrated heat exchanger. It is provided together with the accessories that are the gas line and the convenience kit. Oxygenator module, AMG PMP PEDIATRIC consist of three path, blood path, water path. These three paths, thanks to the particular configuration, allow the bloodtemperature control and gas exchange. The device center consists stainless steel tubes that allow the control of the temperature of the blood. The exchange of heat is between the water (with controlled temperature) that flows outside of steel tubes and the blood that flows inside the steel tubes. The device is surrounded by an outer compartment that contains a microporous membrane of Polymethy|pentene (PMP) consisting of capillary allow fibers that allows gas exchange. The air from the gas mixer is rich in O2 and follows the gas path. It enters through the gas inlet port on the top of the device, goes through microporous PMP fibers and exits from gas escape port, at the same time blood flows outside the microporous fibers. The design of heat exchangers for cooling and rewarming blood in the oxygenator utilizes a biologically inert surface to achieve the desired rate of heat exchange without producing any localized overheating of the blood.

The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) is intended for use in adult Surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. The Advanced Membrane Gas Exchange PMP STERILE (A.M.G. PMP STERILE) for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass. It includes a detachable 4.5 liter blood reservoir.

The Advanced Membrane Gas Exchange and accessories PMP STERILE (A.M.G. PMP STERILE) is a microporous hollow-fiber oxygenator with an integral heat exchanger, used to perform cardiopulmonary bypass or surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. It includes a detachable 4.5 liter blood reservoir. The A.M.G. PMP STERILE is equipped with polymethyl pentene fibres, more hydrophobic than the polyethylene used for the predicate device and so considered a more reliable barrier between the blood pathway and gas pathway of the oxygenator. The A.M.G. PMP STERILE is provided in different configurations: - microporous hollow-fiber oxygenator with temperature probe and pre-connected venous cardiotomy reservoir (“A.M.G. PMP STERILE”), - microporous hollow-fiber oxygenator with temperature probe and without pre-connected venous cardiotomy reservoir (“A.M.G. MODULE PMP STERILE”), - microporous hollow-fiber oxygenator without temperature probe and without pre-connected venous cardiotomy reservoir (“A.M.G. MODULE PMP NO TP STERILE”), - Venous Cardiotomy Reservoir 4500 PMP (“VCR 4500 PMP STERILE”). The device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood. The device can be use with adult patients.

The AMG Adult Hollow Fiber Oxygenator is intended for use in adult Surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. The AMG oxygenating device for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass. It includes a detachable 4.5 liter blood reservoir. The device is used to temporarily substitute the functions of the lung as it supplies oxygen and removes carbon dioxide from the blood. AMG is a single use device.

The AMG Adult Hollow Fiber Oxygenator is intended for use in adult Surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods of up to 6 hours. The AMG oxygenating device for extracorporeal circulation is a microporous hollow-fiber oxygenator with an integral heat exchanger used to perform cardiopulmonary bypass. It includes a detachable 4.5 liter blood reservoir.