Australia - English - Department of Health (Therapeutic Goods Administration)

innervate pty ltd - 61097 - pulmonary function testing filter/mouthpiece - a non-sterile bacterial/viral filter intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to prevent contamination of the parent device and the immediate environment. it is also intended to function as a mouthpiece to facilitate access to the patient's respiratory tract. it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. this is a single patient-use device.

Australia - English - Department of Health (Therapeutic Goods Administration)

device technologies australia pty ltd - 60841 - cardiopulmonary resuscitation feedback device, manual - a device intended as an accessory to a defibrillator to assist a user in cardiopulmonary resuscitation (cpr). it is applied to the chest of a patient to detect the frequency and compression depth of chest compressions.

Australia - English - Department of Health (Therapeutic Goods Administration)

clever first aid pty ltd - 61326 - cardiopulmonary resuscitation mask, single-use - a flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (cpr). the device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during cpr training. the device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. also referred to as a pocket face mask, it is typically used by emergency medical services (ems) or as part of first aid kits. this is a single-use device.

Australia - English - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 60247 - pulmonary transcatheter heart valve bioprosthesis - the harmony transcatheter pulmonary valve (tpv) system is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ? 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.

Australia - English - Department of Health (Therapeutic Goods Administration)

spectrum medical australia pty ltd - 17206 - cardiopulmonary bypass system heating/cooling unit - the spectrum medical quantum heater-cooler is a mains electricity (ac-powered) component of a cardiopulmonary bypass system designed to heat or cool a patient's body by extracorporeal heat exchange with the patient's perfused blood during a cardiopulmonary bypass procedure. it consists of a system to heat or cool a thermal transfer fluid, pumps to provide circulation of the fluid to a heat exchanger, and monitoring and alarm systems. the heater-cooler unit regulates patient blood temperature during cardiopulmonary procedures by allowing extracorporeal blood to be indirectly heated or cooled. the quantum heater-cooler is a fully sealed unit with no high-velocity cooling fans. this mitigates the risk of heater cooler device related nontuberculous mycobacteria infection through the growth and formation of mycobacterial biofilms in the heater-cooler unit and aerosol production and distribution. to manage a patient?s blood temperature, heat transfer fluid (htf) in the heater-cooler is heated using inbuilt heater elements or chilled using phase change material (pcm), which is charge-cooled by a separate cold storage charger. htf is circulated though heat exchangers in the ecc-cpb circuits where the patient?s circulating blood is heated or cooled.

Australia - English - Department of Health (Therapeutic Goods Administration)

spectrum medical australia pty ltd - 64586 - cardiopulmonary bypass system thermal transfer fluid - the heat transfer fluid (htf) (quantum coolflow sm.03.dtx) is a dedicated solution intended to be heated or cooled to a specific temperature by a cardiopulmonary bypass system heating/cooling unit, to heat or cool a patient's body by extracorporeal heat exchange with the patient's perfused blood during a cardiopulmonary bypass procedure. it is pumped to a heat exchanger whereby thermal transfer occurs across a membrane/element; the solution has no direct contact with the patient?s blood. this is a reusable device. the heat transfer fluid (htf) (quantum coolflow sm.03.dtx) has been specially formulated for use with the quantum heater cooler to provide microbial suppression, efficient heat transfer rates, optimum flow path, and non-toxicity. the htf is ready to use.

Australia - English - Department of Health (Therapeutic Goods Administration)

aero healthcare - 63222 - cardiopulmonary resuscitation mouthpiece/cover - a non-sterile device that consists of a mouthpiece with an integrated face/body covering sheet intended to be placed over a patient during cardiopulmonary resuscitation (cpr) to prevent cross-contamination between patient and cpr administrator; it also includes directions/positional markers printed on the cover intended to assist the administrator during cpr. the mouthpiece is designed to be used as a barrier during resuscitation (i.e., "mouth-to-mouthpiece") as an alternative to conventional "mouth-to-mouth". this is a single-use device.

Australia - English - Department of Health (Therapeutic Goods Administration)

defibs plus pty ltd - 60841 - cardiopulmonary resuscitation feedback device, manual - a device intended to assist the rescuer in performing chest compressions at the recommended rate of 100 compressions / minute during cardiopulmonary resuscitation (cpr) of a cardiac arrest patient 16 years or older.

Australia - English - Department of Health (Therapeutic Goods Administration)

spectrum medical australia pty ltd - 35441 - cardiopulmonary bypass system tubing set - the quantum superpac range comprises a set of tubing, connectors, stopcocks, clamps and filters; used in a circuit for cardiopulmonary bypass or other extracorporeal circulation applications as well as for infusion of cardioplegia solutions and other physiological fluids. this is a single use device.

Australia - English - Department of Health (Therapeutic Goods Administration)

spectrum medical australia pty ltd - 64888 - cardiopulmonary bypass system centrifugal pump/heat exchanger - the centrifugal blood pump with integrated heat exchanger is intended to heat and cool blood and to pump the blood through an extracorporeal circuit during cardiopulmonary bypass or during other extracorporeal life support procedures. versions also exist with integrated pressure sensors; or integrated pressure and temperature sensors. this is a single-use device