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

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

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

resmed pty ltd - 37685 - bag, medical device, reusable - personal device holder reusable

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

resmed pty ltd - 41067 - orthodontic appliance, chin cap - chin restraint

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

resmed pty ltd - 42514 - mount, ventilator, mobile - mount, ventilator, mobile

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

resmed pty ltd - 37041 - holder, tube, ventilator - holder, tube, ventilator

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

resmed pty ltd - 61444 - respiratory thermal shield - respiratory thermal shield

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

resmed pty ltd - 57815 - cpap/bipap nasal mask, reusable - single patient reusable cpap/bpap nasal mask

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

resmed pty ltd - 64939 - sleep disorder interpretive software, patient-use - this device is intended as a pre-screening device used to analyse breathing patterns and snore sounds during sleep to assess the risk of obstructive sleep apnea (osa). it is intended to be used by adults 18 years old and above in a non-clinical environment, such as the person's home. the device is not intended to provide a diagnosis and is not intended to substitute for a sleep study or medical advice.

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

resmed pty ltd - 60711 - home cpap unit - the adapters are intended to be used to transfer data between compatible resmed devices. they are intended for use in the home and hospital/institutional environment.

Singapore - English - HSA (Health Sciences Authority)

resmed asia pte. ltd. - general hospital - the apnealink air device is indicated for use by health care professionals (hcp), where it may aid in the diagnosis of sleep disordered breathing for adult patients. apnealink air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. the device uses these recordings to produce a report for the hcp that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. the device is intended for home and hospital use under the direction of a hcp.