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VT75-E1 Quantum Perfusion Blood Oxygenator is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure and temperature during the procedure. The device is limited to 6 hours of use. Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m². VT75-E2 Quantum Perfusion Blood Oxygenator is a diffusion membrane oxygenator, designed to oxygenate and remove carbon dioxide from venous blood during cardiac surgery requiring cardiopulmonary bypass and to measure blood pressure during the procedure. The device is limited to 6 hours of use. Device is intended for Paediatric patients with a Body Surface Area (BSA) ranging from 0.6 m² to 1 m².

The Quantum Perfusion Blood Oxygenator (acronym VT-E) diffusion membrane device is designed to oxygenate blood and remove carbon dioxide from venous blood during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of hollow fibers membrane; while the sweep gas flows into the hollow fiber membrane. The hollow fibers are made of Polymethylpentene (PMP). In this chamber, carbon dioxide moves from the blood to the gas compartment, while oxygen enters into the red blood cells. Then, blood exits the oxygenator with the desired level of oxygen content and saturation, and carbon dioxide content. Sweep gas composition and flow rate are used to control saturation, and oxygen and carbon dioxide content of blood at the outlet of the oxygenator. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with blood are treated with a phosphorylcholine-based biocompatible coating.

Model BB811 and Model BB811-NS: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. Model BB841: Oxygenator with Integrated Arterial Filter: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. Cardiotomy/Venous Reservoir: The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811), Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841), and Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (Non-Sterile) (B811-NS) are collectively referred to as the Affinity Fusion Oxygenator in the summary. The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Balance Biosurface bonded to the blood contacting surface of the device. The integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); The AFFINITY NT Integrated CVR Membrane Oxygenator with Plasma Resistant Fiber is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood, cool or warm the blood and oxygenate and remove carbon dioxide from the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. Indications for Use(541B) The Affinity NT oxygenator with Balance biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. The Affinity NT cardiotomy/venous reservoir (CVR) is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine CPB procedures up to 6 hours in duration.

The Affinity NT Oxygenator with /without Balance Biosurface is a sterile membrane Oxygenator with plasma resistant fiber. It is a single-use gas exchange device with integral stainless-steel heat exchanger. Models 541 and 541B include a cardiotomy/venous reservoir. The Luer cap 1140008-503 that is the 'subject' of this special 510(k) serve as protection of the Luer Access Port. This port can be used to prime the circuit or connect to another support device with a luer connector.

The D100 devices are indicated for use for neonatal patients undergoing surgical procedures requiring cardiopulmonary bypass. The oxygenator is intended to be used for six hours or less. The D101 devices are indicated for use for infant patients undergoing surgical procedures requiring cardiopulmonary bypass The oxygenator is intended to be used for six hours or less

The D100 KIDS and D101 KIDS oxygenators (hereinafter identified as KIDS) consist of an oxygenator with an integrated heat exchanger and hard-shell cardiotomy venous reservoir. The KIDS consist of the following main components • a heat exchanger consisting of a grooved and pleated stainless steel that is placed into a polycarbonate housing with integrated Hansen connectors and is sealed with resin potting at both ends. it controls blood temperature and allows the use of hypothermia or aids in the maintenance of normothermia during surgery. • an oxygenating module element made of a coiled bundle of polypropylene microporous hollow fibers rolled on the heat exchanger sub assembly. The hollow fiber membrane provides oxygenation and carbon dioxide removal from venous blood or suction blood. • a hard shell cardiotomy/venous reservoir attached to the top of the oxygenator by means of a molded fitting joint. It is a single chamber reservoir comprised of a rigid polycarbonate housing with an internal hollow support. The filtering system surrounds the internal hollow support and work as a cardiotomy section in the upper part and as a venous reservoir in the bottom part. It collects and filter blood coming from suckers and from the venous return.

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use. Device is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age). Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U is a diffusion membrane oxygenator, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The device is limited to 6 hours of use. Devices is intended for Adolescent and Transitional Adolescent patients (from 12 to 21 years old age).

Quantum Perfusion Blood Oxygenator devices, VT75-C1U and VT75-C2U, consist of an oxygenator with an integrated arterial filter. The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surqical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. The device has microporous hollow fibers, made of Polypropylene (PP) and with high gas permeability, that allow gas exchange. The integrated arterial filter provides additional protection against air and solid emboli. Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of a hollow fiber membrane, exits the oxygenator with the desired level of gas exchange. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.

The CMO8 Adult PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The CMO8 Adult PMP Oxygenator is intended for up to 6 hours. The Tubing Pack is intended for use in extracorporeal crculation during cardiopulmonary bypass procedures, lasting 6 hours or less.

The CMO8 Adult PMP oxygenator (CMO8) is a hollow fiber membrane oxygenator with an integrated heat exchanger. The CMO8 facilitates the gas exchange into and out of the blood, and the regulation of blood temperature during cardiopulmonary bypass. The CMO8 is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces. The qas exchanger part of the CMO8 is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the CMO8 is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated. The Tubing Pack, which contains blood lines, gas lines, a venous reservoir and the CMO8 Oxygenator, is a component of a cardiopulmonary bypass procedure that facilitates extracorporeal circulatory support for a term of up to 6 hours.

The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to six hours during cardiopulmonary bypass surgery. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is intended to be used in an extracorporeal perfusion circuit to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to 6 hours in duration. The CVR is also intended for use during vacuum assisted venous drainage (VAVD) procedures. The Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface is also intended for use after open heart surgery to collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement. The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. The Affinity Fusion oxygenator with integrated arterial filter and Cortiva bioactive surface is designed to filter from the circuit microemboli larger than the specified micron size for periods up to 6 hours during CPB surgery.

The Affinity Fusion Oxygenator is intended to be used in an extracorporeal perfusion blood circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration. The Affinity Fusion Oxygenator contains both an integrated arterial filter and integrated heat exchanger. The Affinity Fusion Oxygenator is a microporous, hollow-fiber, gas-exchange devices available with Cortiva BioActive Surface or Balance Biosurface bonded to the blood contacting surface of the integrated arterial filter is designed to filter from the circuit microemboli larger than the specified micron size from the circuit for periods up to six hours during cardiopulmonary bypass surgery. Some models of the Affinity Fusion Oxygenator are packaged with an Affinity Fusion Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface which is designed to be an integral part of a cardiopulmonary bypass circuit for use during cardiac surgery. The Affinity Fusion CVR is designed to collect venous and cardiotomy suctioned blood during routine cardiopulmonary procedures up to six (6) hours in duration. Additionally, the Affinity Fusion CVR may be used during vacuum assisted venous drainage (VAVD) procedures and collect autologous blood from the chest and to aseptically return the blood to the patient for blood volume replacement during open heart surgery.

The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration.

The Abiomed OXY-1 System provides extracorporeal circulation for cardiopulmonary bypass support for up to six hours in duration. The OXY-1 System includes: - A Disposable pump and oxygenator . - A Pump Driver (blood pump) ● - Blood tubing . - A Console for controlling the pump and managing gas flow . These components are designed to operate together, simplify operation, and reduce the overall equipment footprint at the bedside.

The CentriMag™ Pre-connected Pack is indicated for use with the CentriMag™ Acute Circulatory Support System to provide physiologic gas exchange of the blood and to pump a patient's blood through an extracorporeal circuit for periods lasting less than six (6) hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory necessary for open surgical procedures on the aorta or vena cava.

CentriMag Pre-connected Pack is to be used with the CentriMag™ Acute Circulatory Support System components (console, motor, flow probe and monitor) to provide extracorporeal circulation for full or partial cardiopulmonary bypass support for less than 6 hours. The CentriMag™ Pre-connected Pack contains sterile disposable components: a blood pump, oxygenator, and priming bag pre-connected by tubing. The pack also includes disposable accessories commonly used in the setup of pump and oxygenator connections to the cardiopulmonary bypass extracorporeal circuit.

Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U and Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U are diffusion membrane oxygenators, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass, to measure blood pressure and temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use. Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U and Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U are diffusion membrane oxygenators, designed to provide gas exchange during cardiac surgery requiring cardiopulmonary bypass and to measure temperature during the procedure. The integrated arterial filter provides additional protection against air and solid emboli. The devices are limited to 6 hours of use. Devices are intended for adult patients.

Quantum Perfusion Blood Oxygenator devices (acronym VT-C) consist of an oxygenator with an integrated arterial filter. The Quantum Perfusion Blood Oxygenator device is designed to provide gas exchange during cardiac surgical procedures requiring cardiopulmonary bypass for a maximum duration of 6 hours. The device has microporous hollow fibers, made of Polypropylene (PP) and with high gas permeability, that allow gas exchange. The integrated arterial filter provides additional protection against air and solid emboli. Blood enters the oxygenator through the blood inlet connector, flows through a blood chamber, touching the outer surface of a hollow fiber membrane, exits the oxygenator with the desired level of gas exchange. The device is non-toxic, non-pyrogenic, sterilized by ethylene oxide and packaged in a single box. All the device surfaces in contact with a phosphorylcholine-based biocompatible coating.