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

emergo asia pacific pty ltd t/a emergo australia - 57814 - cpap/bipap face mask, reusable - the full face mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (cpap) or bi-level system. the full face mask is: ? to be used by adult patients (greater than 66 lb / 30 kg) for whom positive airway pressure therapy has been prescribed. ? intended for single-patient re-use in the home environment and multi-patient re-use in the hospital / institutional environment.

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

emergo asia pacific pty ltd t/a emergo australia - 57815 - cpap/bipap nasal mask, reusable - channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (cpap) or bi-level system: to be used by adult patients (greater than 66 lb / 30 kg) for whom positive airway pressure therapy has been prescribed and intended for single-patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.

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

emergo asia pacific pty ltd t/a emergo australia - 60712 - home bpap unit - the bpap system is a bi-level positive airway pressure device, which is intended to provide non-invasive ventilation for patients with obstructive sleep apnea (osa) and respiratory insufficiency. these devices are intended for adult patients by prescription in the home or hospital/institutional environment.

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

emergo asia pacific pty ltd t/a emergo australia - 60711 - home cpap unit - the system is a cpap (continuous positive airway pressure) device designed for the treatment of adult obstructive sleep apnea (osa) only, either in the hospital or at home.

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

emergo asia pacific pty ltd t/a emergo australia - 58038 - joint/spinal manipulator - the activator adjusting instrument is intended for chiropractic adjustment of the spine and extremities and is for external use only.

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

emergo asia pacific pty ltd t/a emergo australia - 41670 - radiology picture archiving and communication system application software - the mri-us fusion is a software application to be used by clinicians in the clinic or hospital for 2-d and 3-d visualisation, image registration, and fusion of magnetic resonance and ultrasound images for mapping planning information of the prostate gland and region of interest. the software features also include multi-modality data communication, surface and volume rendering, segmentation, multi-planar reconstruction, organ delineation, region of interest delineation, landmark selection, measurements and data reporting.

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

emergo asia pacific pty ltd t/a emergo australia - 45018 - non-implantable needle guide, single-use - the biopsy kit is intended to be used with the isr'obot mona lisa. the probe sheath provides a protective cover system for the ultrasound transducer usage in the rectum to prevent microbial and other contamination. the needle guide serves as a guidance for a biopsy needle during the procedure. the kit consists of a needle guide, an ultrasound probe sheath, a plastic drape, and a pouch of biopsy papers.

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

emergo asia pacific pty ltd t/a emergo australia - 44054 - surgical procedure kit, orthopaedic, reusable - orthopaedic instruments to perform an orthopaedic surgical procedure. they are reusable after the appropriate cleaning/sterilizing of the instruments/reusable products.

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

emergo asia pacific pty ltd t/a emergo australia - 58510 - vial transfer spike - the mix2vial is intended for fast, efficient and safe transfer of drugs from one vial into another, followed by aspiration into a syringe without using any needle.

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

emergo asia pacific pty ltd t/a emergo australia - 46653 - spinal fixation plate, non-biodegradable - the system is intended for anterior screw fixation to the cervical spine (c2-c7). the system is indicated for use in the immobilization and stabilization of the spine as an adjunct to fusion in patients with: - ddd (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) - spondylolisthesis - trauma (i.e. fractures or dislocations) - tumors - deformity (defined as kyphosis, lordosis or scoliosis), - pseudarthrosis - failed previous fusion - spinal stenosis