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

airlife australia holdings pty ltd - 36086 - resuscitator, pulmonary, manual, single use - the resuscitator is a single patient use resuscitator intended for pulmonary resuscitation of adults, infants, and pediatric patients.

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

fastaid - 36086 - resuscitator, pulmonary, manual, single use - the manual resuscitator is a hand-held device used to provide ventilation to a patient who are apneic or exhibit inadequate respiration. the device may be used in ambulances, emergency rooms, or intensive care areas throughout hospitals. manual pulmonary resuscitators include an oxygen reservoir, tubing, and a connector for attachment to a mask or airway tube. this is a single use device.

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

medtronic australasia pty ltd - 17206 - cardiopulmonary bypass system heating/cooling unit - the spectrum medical quantum heater-cooler is intended to circulate temperature regulated heat transfer fluid through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting six hours or less.

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

hospital products australia pty ltd - 36086 - resuscitator, pulmonary, manual, single use - single patient use pulmonary resuscitator for manual breathing support.

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

livanova australia pty ltd - 31715 - sensor, blood gas, cardiopulmonary bypass, in-line - the b-capta arterial cuvettes are intended for use in adult and pediatric surgical procedures requiring cardiopulmonary bypass. the arterial cuvettes are for arterial partial oxygen pressure and temperature monitoring. the cuvettes are sterile and single use.

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

edwards lifesciences pty ltd - 47733 - cardiopulmonary bypass cannula, femoral - femoral access arterial cannula. wire-reinforced and thin-wall cannula with introducer that passes over a 0.038" (0.96 mm) guidewire. the clear proximal section is not reinforced to allow clamping and terminates in a barbed connector. the cannula includes two barium stripes on the tubing to aid in placement. it comes in 16, 18, and 20fr sizes for use in adults. edwards lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (? 6 hours) cardiopulmonary bypass. vessel access (venous or arterial) is left to the discretion of the physician. femoral access cannulae may be used in paediatric populations or adult populations based on flow rate requirements and individual patient anatomy.

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

mgc diagnostics australia pty ltd - 17250 - spirometer/pulmonary function analyser syringe - this device is designed for testing and calibrating flow and volume measurement devices by injecting small volumes of gas into a spirometer, pulmonary function analyser, or other diagnostic pulmonary testing device for calibration or reference. this device is used by persons trained in the calibration procedures of the equipment under test. this is a reusable device.

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

livanova australia pty ltd - 31715 - sensor, blood gas, cardiopulmonary bypass, in-line - the b-capta venous cuvettes are intended for use in adult and pediatric surgical procedures requiring cardiopulmonary bypass. the venous cuvettes are for venous oxygen saturation, haematocrit/hemoglobin and temperature monitoring. the cuvettes are sterile and single use.

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

mgc diagnostics australia pty ltd - 37068 - valve, pulmonary function - two-way non-rebreathing valves are intended for use as a component of a respiratory circuit for spontaneously breathing patients to enable two-way non-rebreathing. the direction of flow through the valve is indicated with arrows marked on the valve body. these valves are indicated for use in pulmonary function testing, exercise testing, and respiratory research and custom applications involving adults and paediatric patients. these valves are not intended for use involving critical care or life support, ventilation or anaesthesia.

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

bird healthcare pty ltd - 36146 - stress exercise monitoring system, pulmonary - the cardiovit cs-200 series system is a multichannel electrocardiograph device intended to be used by trained medical professionals or under direct supervision of a licensed health care practitioner, in hospitals, clinics, physician offices and outreach centres for cardiopulmonary diagnosis in adult and paediatric patients. the ergospiro option additionally is a cardio-pulmonary exercise system providing breath-by-breath-measurements of flow, oxygen uptake and carbon dioxide production.