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

device technologies australia pty ltd - 61326 - cardiopulmonary resuscitation mask, single-use - a mask intended to be used to deliver mouth-to-mouth resuscitation during cpr.

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

bird healthcare pty ltd - 35282 - pulmonary function analysis system, adult - to monitor lung function through the measurement of airway resistance, reactance and other lung function parameters. the device assists physicians in the diagnosis, treatment selection and evaluation of efficacy by providing accurate, reproducible and high quality lung-function data

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

medtronic australasia pty ltd - 31714 - cardiopulmonary bypass system gas control unit - the quantum ventilation module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation.

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

spectrum medical australia pty ltd - 31714 - cardiopulmonary bypass system gas control unit - the quantum ventilation module is intended for the continuous monitoring of critical clinical parameters during procedures that require extracorporeal circulation. the quantum ventilation module is an accessory that only works with the quantum workstation. parameters provided by the quantum ventilation module include: ? measurement of up to three blood flow channels and arterial and venous flow differential ? indication of gas bubbles ? extracorporeal gas flow measurements (o2, co2, gas flow, and co2 removal) ? predicted po2 and pco2 ? temperature ? up to three circuit pressure channels ? reservoir level indication ? two channels of vacuum ? blend and control gas flow (air/o2/co2)

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

midmed pty ltd - 57981 - pulmonary resuscitator, pneumatic, single-use - intended to provide pressure-limited, flow controlled ventilatory support for short-term emergency ventilatory support for both breathing and non-breathing patients while being monitored by a clinician or trained operator. the go2vent is a single patient, multiple use device. indicated for patients in need of emergency, short term, constant flow, pressure cycled ventilatory support and patients unable to maintain an adequate acid-base status during unassisted ventilation.

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

medtronic australasia pty ltd - 64585 - cardiopulmonary bypass system heat exchanger, single-use - heat exchangers in the cardioplegia and arterial circuits use the heater transfer fluid (htf) from the heater-cooler to warm or cool the priming solution pre-bypass support, as well as warm or cool the patient?s blood during bypass support and post-bypass support as needed. they are designed to operate for a maximum of 6 hours.

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

intersurgical australia pty ltd - 61097 - pulmonary function testing filter/mouthpiece - to reduce the risk of bacterial and viral contamination within critical and respiratory care breathing systems.

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

sonic equipment australia pty ltd - 61097 - pulmonary function testing filter/mouthpiece - a single use sensor (mouthpiece) that fits the fim medical spirolyser. this fits into the spirolyser housing allow the patient to blow though it and recordings made on the spirolyser software. it is packaged in such a way to allow a no touch technique to be used in it's insertion and disposal. the device is invasive via the oral cavity only.

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

the weringa group pty ltd - 64339 - cardiopulmonary physiologic analysis software - to be installed on a computer/workstation to facilitate the measurement of arterial oxygen saturation (sp02), pulse rate and respiratory rate vital physiologic parameters it is intended to display, store, and allow communication of the physiological data

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

rgn technology pty ltd - 57981 - pulmonary resuscitator, pneumatic, single-use - components: mechanical ventilator, catheter mounth, oxygen hose, profix? fixing device, hme filter. patients in need of emergency, short term, constant flow, pressure cycled ventilatory support. patients unable to maintain an adequate acid-base status during unassisted ventilation.