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

resmed pty ltd - 57814 - cpap/bipap face mask, reusable - resmed mask is intended to be used by patients who have been prescribed non-invasive positive airway pressure (pap) therapy such as cpap or bi-level therapy. the mask is intended for single patient re-use in the home and multi-patient re-use in the hospital/institutional environment.

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

resmed pty ltd - 12050 - humidifier, heated - resmed humidifiers are indicated for the humidification of air delivered to the airway during continuous, automatic and bilevel therapy. resmed humidifiers are used in conjunction with resmed flow generators

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

bresmedical pty ltd - 61496 - surgical planning/navigation-enhancement system - the implanav system is an integrated software-hardware solution able to track in real time the position of a dental drill tip in action and to create its dynamic representation over a surgical virtual planning based on a tomographic scan. the implanav system aims to reduce the risks and improve the outcome of the operation as an additional verification and monitoring instrument supplementary to the equipment already used by the practitioner on a routine basis. more specifically, the implanav software allows a surgical planning through the virtual insertion or implants in a multi-view interface. in its navigation function the system aims to give an indicative status of the surgical drill during the surgical procedure with respect to the virtual planning. the system can also be used for educational purposes. in practice, the implanav navigation and dental drill guide automatic design technology can be applied to plastic or bone-like phantoms in order to simulate or reproduce a surgical procedure into a context such as a surgical skills laboratory. the implanav system should only be used during surgery by oral surgeons, dentists, orthodontists, maxillofacial surgeons while it can be used by students and other professionals for training purposes on anatomical replicas instead of real patients. the system is only meant to be used with the reference set of instruments provided by the manufacturer as part of the implanav system. the implanav system does not aim to replace conventional surgical procedures in oral and maxillo-facial implant placement. any use of the system which is not merely additional guidance in implant placement is considered a misuse.

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

resmed pty ltd - 37597 - filter, humidifier, heat/moisture exchanger - filter, humidifier, heat/moisture exchanger to be used to heat and humidify air and other respiratory gases inspired by the patient.

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

resmed pty ltd - 37591 - cpap/bipap nasal mask, single-use - the nasal mask is intended for single use by patients who have been prescribed continuous positive airway pressure (cpap) or bi-level (bipap) therapy.

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

resmed pty ltd - 42601 - connector, breathing circuit, reuseable - a reusable device used to connect a breathing circuit to a tube, pap mask, or other breathing circuit components.

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

resmed pty ltd - 35426 - alarm, airway pressure - a warning device that monitors a patient's upper airway pressure during mechanical ventilation. based on preset physiological parameters the device will signal a warning.

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

resmed pty ltd - 37591 - cpap/bipap nasal mask, single-use - the nasal mask is intended for single use by patients who have been prescribed continuous positive airway pressure (cpap) or bi-level (bipap) therapy.

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

resmed pty ltd - 36862 - patient monitor module, interface - patient monitoring system

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

resmed pty ltd - 36534 - power supply, battery pack - power supply battery pack