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Vanguard 4:1 Blood cardioplegia sets are cardiopulmonary bypass devices allowing cardioplegia fluid delivery. They also regulate cardioplegia fluid temperature and trap air emboli. The devices are intended to be used for 6 hours or less.

The Vanguard Blood Cardioplegia Systems are single-use, non-toxic, non-pyrogenic and supplied sterile in individual packs. They are cardiopulmonary bypass devices allowing cardioplegia fluid delivery; they also regulate cardioplegia fluid temperature and trap air emboli. Vanguard devices are indicated for use for patients undergoing surgical procedures requiring cardiopulmonary bypass procedures. These Vanguard Blood Cardioplegia Systems are circuits designed to administer cardioplegic solution and they can be used up to 6 hours. The Vanguard Blood Cardioplegia Systems are the modified version of the disposables currently marketed in the SORIN BLOOD CARDIOPLEGIA SYSTEM (K934763) and the NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS (K934847).

For XTRA Collection sets: "The XTRA Autotransufion System (including the XTRA Collection sets) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: - Cardiovascular - Orthopedics - Thoracic - Transplant surgery - Emergency (Trauma) - Neurosurgery - Obstetrics and Gynecology - Urology" For XTRA Sequestration set X: "The XTRA Autotransufion System (including the XTRA Sequestration set X) is indicated for intraoperative recovery of blood, washing of blood collected in the postoperative period, and preoperative sequestration (with indirect patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: - Cardiovascular - Orthopedics - Thoracic - Transplant surgery - Emergency (Trauma) - Neurosurgery - Obstetrics and Gynecology - Urology"

XTRA Sequestration set X: The XTRA Sequestration set X is a single use sterile device made of plastic materials (mainly PVC) and it should be used in combination with a Bowl set and the XTRA autologous blood separation equipment unit (XTRA Equipment) for preoperative sequestration, aimed at autotransfusion. The XTRA Sequestration set consists of a system of tubing lines and bags, the autologous blood is recovered from the patient through routine hemodilution techniques and it's mixing with an anticoagulant in a blood bag, when blood is sufficient to fill the bowl set blood processing starts in order to separate blood into red blood cells (RBC), platelet poor plasma (PPP) and concentrated platelets or platelet rich plasma (PRP). In the bowl, because of centrifuqal force the blood components are separated and the RBC. PPP and PRP are collected into collection bags while the undesired elements (lysed cells, residuals, water, etc.) are discarded into a waste bag. The blood processed and collected in the bags is then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product. The XTRA Sequestration set is a modified version of the disposable currently marketed in the XTRA autotransfusion system (K101586). XTRA Collection sets: The XTRA Collection sets are single use sterile devices made of plastic materials (mainly PVC) and they should be used in combination with the XTRA autologous blood separation equipment unit (XTRA Equipment) for intraoperative cell salvage and/or postoperative cell salvage, aimed at autotransfusion. The XTRA Collection sets consist of a blood collection reservoir, an aspiration and anticoagulation line, a vacuum extension line and a system of tubing lines, the autologous blood is collected from the field by mean of a vacuum source (vacuum pump provided into the equipment) into a blood collection reservoir and filtered to remove large clots, debris and microaggregate and blood defoaming. From the reservoir, the blood may be immediately used for direct administration to the patient in case of emergency, otherwise, the collected blood is processed with a Bowl set (wash set) and then reinfused to the patient through gravity. The system does not provide any mechanical means of reinfusing the product. The XTRA Collection sets are a modified version of the disposables currently marketed in the XTRA autotransfusion system (K101586) and in the XRES/XRES 120um Blood Collection Reservoirs (K131103).

The Quantum Perfusion Hybrid System is intended to collect, defoam and filter venous and suction blood during cardiopulmonary bypass. The device is intended to be used for periods up to six hours. The device is intended for adult patients.

The Quantum Perfusion Hybrid System is a system, including a blood reservoir consisting of an hardshell and softshell reservoir. The combination of defoaming bodies and filtering media of venous/vent and cardiotomy side allows both the filtration of debris and the retention of air bubbles. Product configuration includes, together with the Hybrid System, dedicated spare parts: an adapter 1/2" – 3/8"; a spare cap set; a blood sampling set. The device is intended to be used for periods up to six hours. The Quantum Perfusion Hybrid System is a sterile device with non-pyrogenic fluid pathways, sterilized by ethylene oxide, conceived for single use only and is not to be re-sterilized by the user; the device has a declared shelf life of 2 years.

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.

The MVR Venous Reservoir Bag is indicated for use during cardiopulmonary bypass surgery in an extracorporeal circuit utilizing a membrane oxygenator for up to 6 hours in duration. The MVR Holder (Model MVR-SH) is indicated for use with the MVR Collapsible Venous Reservoir Bag.

The MVR Venous Reservoir Bag, with or without Cortiva bioactive surface, is a single-use, sterile, nonpyrogenic variable volume device used in conjunction with a membrane oxygenator during cardiopulmonary bypass (CPB) surgery. It is sterilized using ethylene oxide. It is designed to accommodate blood from the patient and suctioned blood from the cardiotomy reservoir. The internal screen of the venous reservoir is designed to assist in tramping air, which may enter the venous reservoir during priming or perfusion on the inlet side of the reservoir. Air trapped in the venous reservoir bag can be removed using the one-way stopcock located at the top of the reservoir. Blood that comes from the patient flows into the reservoir and is delivered through a pump to the oxygenator and other axillary devices, and back to the patient. The oxygenator can be connected to a heater/cooler device, recirculation circuit, cardioplegia circuit, and the main blood path. Products coated with Cortiva bioactive surface include a "CB" prefix in the model number. The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated surface enhances blood compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva bioactive surface contains nonleaching heparin derived from porcine intestinal mucosa.

The BMR1900 PHISIO Closed Venous Reservoir Bag is intended to be used in cardiopulmonary bypass procedures for periods of up to six hours.

The BMR1900 PHISIO Closed Venous Reservoir Bag (hereinafter BMR1900) is a softshell, flexible, polyvinylchloride bag designed for use in cardiopulmonary bypass surgery for periods up to six hours. It is supplied sterile with non-pyrogenic fluid pathways, for single use only, and is not to be resterilized by the user. As for the unmodified device, the BMR1900 PHISIO. is composed of the following elements: - · A collapsible bag that serves as an in-line closed venous reservoir to contain blood volume. - · An integral 105 micron polyester filter screen which is mainly intended to facilitate the removal of large air bubbles from the blood. - A dual four-wav stopcock assembly used to manually purge the air captured by the filter screen or to administrate drugs or other solutions as needed during the cardiopulmonary bypass procedure. - A 1/2" venous blood inlet port and a 3/8" blood outlet port. - Connectors integral to the blood inlet port that are used to measure temperature and saturation/hematocrit of the incoming blood using external monitoring equipment, as needed. The BMR1900 PHISIO is designed with a 1900 mL maximum operating volume and a minimum operating volume equals to 300 mL and can be used at any flow rate up to 6 liter per minute. The venous blood inlet/outlet ports and the dual four-way stopcock assembly are opposite located with respect to the horizontal axis: the formers are placed in the bottom of the device while the latter at the top of the bag. Considering the vertical axis, both modified and unmodified devices present the blood inlet port with the integral cardiotomy inlet placed on one side of the bag while the blood outlet port is located on the opposite side of the bag. Blood enters the bag through the inlet port and passes through a polyester filter screen before exiting the bag through the outlet port. The purpose of the filter is to facilitate the removal of large air bubbles from the blood. The BMR1900 PHISIO will be available with two configurations that differ only for the orientation of the venous blood inlet. The BMR1900 PHISIO. has the connector of the venous blood inlet right oriented (figure 1) while the BMR1900 L PHISIO. has the connector of the venous blood inlet left oriented (figure 2) The modified device is modified version of the currently marketed BMR1900 PH.I.S.I.O product

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 MiniGuard™ Arterial Safety Valve is intended to be used in an Extracorporeal Circuit during cardiopulmonary bypass procedures for the prevention of retrograde flow.

The MiniGuard Arterial Safety Valve ensures unidirectional flow in a blood filled line by means of a duckbill check valve located in the valve housing. If the line becomes pressurized, the check valve would automatically close and prevent flow in the reverse direction. A directional arrow as shown in Figure 12.1 below is printed on the valve to provide the user with a visual indication of blood flow. The MiniGuard Arterial Safety Valve consists of a an inlet and outlet housing made from Terlux 2802 HD ABS and a duckbill made from GLP-38L6 Off White Silicone rubber. The MiniGuard is sold with a cap made from PVC, 6811G-05. The cap is removed before use and has no patient contact. No colorants or adhesives are used on the valve.

The Intersept filtered cardiotomy reservoir with Cortive surface is indicated for use in the cardiopulmonary bypass circuit during surgery for: - an air/fluid separation chamber - a temporary storage reservoir for priming solution and blood - the filtration of particulates from bank blood and the storage and filtration of blood recovered from the field by suction - the addition of medications or other fluids.

The Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface is a single-use, device with a sterile, nonpyrogenic fluid path. The maximum capacity of each reservoir is 2,600 mL. The maximum recommended flow rate is 2 liters per minute (LPM). Each reservoir has eight luer or 0.6 cm (0.25 in) ID access ports; four suction access ports, two pre-defoamer and two post-defoamer access ports. One of the post-defoamer access ports is intended for use as a vent. Each Intersept Filtered Cardiotomy Reservoir contains an open cell polyurethane defoamer with a 20-micron microaggregate filter covered with a polyester sleeve.

INSPIRE SVR 1200 with Ph.I.S.I.O. coating is intended for use in adult surgical procedures requiring cardiopulmonary bypass. It collects and handles venous blood from cardiotomy reservoir. The INSPIRE SVR 1200 is intended to be used for 6 hours or less. INSPIRE SVR 1200 with Ph.I.S.I.O. coating is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects and handles venous blood and suction blood from cardiotomy reservoir. The INSPIRE SVR 1200 is intended to be used for 6 hours or less.

The Sorin INSPIRE SVR 1200 (hereinafter referred to as INSPIRE SVR 1200) is a flexible PVC soft shell venous reservoir bag. This reservoir may be attached to the INSPIRE 6F C and INSPIRE 8F C oxygenator systems using a molded fitting connected to the gas exchange module. The blood contacting surfaces of this device are coated with a phosphorylcholine-based (Ph.I.S.I.O.) coating that provides a uniform surface. The device is provided with a 1/2" venous inlet connector and a 3/8" blood outlet connector. The venous inlet has an integral cardiotomy reservoir connector to allow receipt of blood from both venous cannulation and from a cardiotomy reservoir. The INSPIRE SVR 1200 can be operated at flow rates up to 8 liters per minute (I/min) and has a maximum reservoir volume of 1325 mL. The INSPIRE SVR 1200 soft shell venous reservoir is similar to the predicate devices as it consists of a soft PVC material and is used to collect blood during cardiopulmonary bypass procedures lasting up to 6 hours. The intended use and principles of operation are consistent with the predicate devices. It differs from the predicate devices in volume and dimensions, length of purge lines, and it includes a mounting backplate. The device is ethylene oxide sterilized, has a non-pyrogenic fluid path and is for single use only.