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

vyaire medical pty ltd - 14361 - ventilator, neonatal/paediatric - a device providing automatic cycling used to assist/control alveolar ventilation by delivering an appropriate volume of gas to the respiratory airways. respiratory gases are delivered to the patient's airway through a mouthpiece, mask, or endotracheal tube. the device provides respiratory support to neonates and paediatric patients in intensive care units and for transport and includes high frequency oscillation and the delivery of nitric oxide and other special applications that pertain to specific clinical conditions. the device is used with breathing circuits and may be used with airway monitoring devices.

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

vyaire medical pty ltd - 17460 - electrode, electrocardiograph, neonatal - an accessory to an ecg intended for use on neonatal patients, that is applied to the surface of the body to transmit the electrical signal on the body surface to a processor, which produces a graphic representation of the electrical activity of the heart. this device is disposable/single use.

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

vyaire medical pty ltd - 37258 - transducer, toco - a device that converts birthing contractions to electrical signals the results are displayed on a seperate.

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

airlife australia holdings pty ltd - 12050 - humidifier, heated - the vyaire heated humidifier is intended to add moisture to, and to warm, the breathing gases for administration to a patient. gases available for medical use do not contain sufficient moisture and may damage or irritate the respiratory tract or desiccate secretions of patients whose supraglottic airways have been bypassed. this product is nonsterile, reusable, and intended to be used in professional healthcare environments under the supervision of a licensed healthcare practitioner.

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

airlife australia holdings pty ltd - 37340 - probe, thermometer, reusable - the reusable infant temperature probes are intended to be used in monitoring temperature. they are designed for use with ge healthcare giraffe? and panda? systems in neonatal intensive care unit. the reusable infant temperature products are intended to be reused after cleaning and disinfection. these devices are indicated for use by qualified medical personnel only.

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

emergo asia pacific pty ltd t/a emergo australia - 37498 - oxygen therapy delivery system - non-sterile tubing intended to deliver air/oxygen or medical gases during respiration or anaesthesia. they may be heated.

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

emergo asia pacific pty ltd t/a emergo australia - 44225 - oxygen/air breathing gas mixer - intended to be as an accessory for ventilator to provide mixing of medical grade air and oxygen for the ventilator.

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

emergo asia pacific pty ltd t/a emergo australia - 36289 - transport electric ventilator - the ltv2 series ventilators are intended to provide continuous or intermittent ventilatory support for the care of the individuals who require mechanical ventilation. the ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. specifically, the ventilator is applicable for adult and pediatric patients weighing at least 10 kg (22 lb.) who require the following types of ventilator support: ? positive pressure ventilation, delivered invasively or non-invasively. ? assist/control, simv, cpap, or nppv modes of ventilation. ? breath types: volume control, pressure control, pressure support, sigh, and spontaneous. the ventilator is suitable for use in institutional settings and intra-hospital transport..

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

airlife australia holdings pty ltd - 42476 - catheter mount, single-use - the intended use of patient circuits and components is to provide a conduit for gases between patient and equipment in general anesthesia, transport and/or medical mechanical ventilation.

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

vyaire medical pty ltd -