Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 41187 - audiometer, computer-controlled - intended for the measurement of hearing, most commonly for measuring the hearing threshold level. this is an electroacoustic device in which the test procedure is controlled by a computer or microprocessor.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 57812 - radiology dicom image processing application software - the device is intended to utilise dicom 3.0 compliant magnetic resonance image datasets, acquired from compatible mr systems, to display the internal structure of the abdomen.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 57812 - radiology dicom image processing application software - mrcp is a general tool for the quantitative evaluation of the pancreatobiliary system including the gallbladder and intrahepatic ducts. it is not indicated for use in any specific demographic or population.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 14074 - tourniquet, pneumatic - this device is intended to be used only with a delfi bfr tourniquet cuff by a physician or physician?s designated licensed healthcare practitioner to preoperatively and/or postoperatively exert enough pressure on the arterial blood flow in a patient?s extremity to reduce or totally occlude blood flow into the limb.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 17230 - cuff, tourniquet, reusable - these devices are intended to be used only with a delfi pts for blood flow restriction tourniquet instrument by a physician or physician?s designated licensed healthcare practitioner to preoperatively and/or postoperatively exert enough pressure on the arterial blood flow in a patient?s extremity to reduce or totally occlude blood flow into the limb.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 30110 - stand, - this device is intended to provide support and stability during horizontal movement of a delfi pts for blood flow restriction tourniquet instrument and to store the system?s tourniquet cuffs and matching limb protection sleeves accessories.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 35374 - stocking, stockinet - these devices are intended to be used only with a matching delfi pts bfr easi-fit tourniquet cuff by a physician or physician?s designated licensed healthcare practitioner to preoperatively and/or postoperatively protect a patient?s limb from possible wrinkling, pinching, and shearing of the skin and soft tissues of the limb.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 35615 - surgical staple, non-bioabsorbable - the endoscopic stapler reloads has applications in general, abdominal, gynaecologic, paediatric and thoracic surgery for resection, transection and creation of anastomoses. this is a single-use device. the device may also be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney, and spleen.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 59871 - endoscopic manual linear cutting stapler, single-use - the endoscopic stapler handle has applications in general, abdominal, gynaecological, paediatric and thoracic surgery for resection, transection and creation of anastamoses. this is a single-use device. the device may also be used for transection and resection of liver substance, hepatic vasculature, biliary structures, pancreas, kidney, and spleen.

Austraalia - inglise - Department of Health (Therapeutic Goods Administration)

aa-med pty ltd - 59016 - subcutaneous glucose sensor - the sensor is comprised of an applicator, sensor pod, and sensor wire. the sensor wire is made of silver and platinum with layers of membranes, one of which includes glucose oxidase. the applicator helps to insert the sensor wire inside the sensor pod under the skin. once inserted, the wire measures glucose levels in interstitial fluid for up to 10 days. the dexcom g6 continuous glucose monitoring system (dexcom g6 system or g6) is a glucose monitoring system indicated for persons with diabetes mellitus age 2 years and older where self-monitoring of blood glucose (smbg) is indicated. the dexcom g6 system is designed to replace fingerstick blood glucose (bg) testing for treatment decisions. interpretation of the dexcom g6 system results should be based on the glucose trends and several sequential readings over time. the dexcom g6 system also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. the dexcom g6 system is intended for use by patients at home and in healthcare facilities. the dexcom g6 cgm system is also designed to reliably and securely transmit glucose management data to digitally connected devices, including automated insulin dosing (aid) systems, and is intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.