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

abbott medical australia pty ltd - 60242 - aortic heart valve bioprosthesis - the sjm epic supra heart valve is a triple-composite bioprosthetic heart valve manufactured from select porcine aortic valve cusps. the sjm epic supra valve is intended as a replacement for a diseased or malformed native aortic heart valve. it may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

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

abbott medical australia pty ltd - 60242 - aortic heart valve bioprosthesis - the sjm epic aortic valve is a triple-composite bioprosethetic heart valve manufactured from select porcine aortic valve cusps. the sjm epic aortic valve is intended as a replacement for a diseased, damaged or malformed aortic native heart valve. it may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

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

abbott medical australia pty ltd - 60244 - mitral heart valve bioprosthesis - the sjm epic mitral valve is a triple-composite bioprosthetic heart valve manufactured from select porcine aortic valve cusps. the sjm epic mitral valve is intended as a replacement for a diseased, damaged or malformed mitral native heart valve. it may also be used as a replacement for a previously implanted mitral prosthetic heart valve.

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

medtronic australasia pty ltd - 35853 - lead, defibrillator, implantable - unipolar, epicardial, oval patch leads are designed for the delivery of cardioversion and defibrillation. they are intended for use only with a medtronic implantable tachyarrhythmia control device. unipolar, epicardial, oval patch leads are designed for the delivery of cardioversion and defibrillation. they are intended for use only with a medtronic implantable tachyarrhythmia control device.

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

epic medical pty ltd - 46542 - elastomeric infusion pump system - the smarteztm pumps are intended for continuous and/or intermittent infusion of fluids for general infusion use, including antibiotic delivery, chemotherapy and pain management. routes of administration include the following: ? intravenous ? intra-arterial ? subcutaneous ? intramuscular ? epidural the device is also intended for continuous and /or intermittent delivery of fluids (such as local anaesthetics or narcotics) to surgical wound sites and /or close proximity to nerves for preoperative, perioperative and postoperative regional anaesthesia and pain management. routes of administration may be intra-operative, perineural or percutaneous.

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

epic medical pty ltd - 16858 - port, injection, catheter - catheter adaptor is the interface for any standard foley catheters. when connected to the drainage port on a catheter and engaged with a prosealtm injector (syringe adaptor), fluid can be administered to the catheter in a closed system.

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

epic medical pty ltd - 64467 - luer/non-iso80369-standardized linear connector, single-use - an interface between closed system connectors and other luer lock connectors for fluid transfer.

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

epic medical pty ltd - 64997 - non-iso80369 formatted bag access spike - the iv bag spike is an adaptor between iv bags and components for closed system fluid transfer. the connector for fluid line injection site on the iv bag spike and all its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. the use of this component and its appropriate closed system connecting component reduces the risk of microbial ingress for up to 168 hours or 7 days.

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

epic medical pty ltd - 65151 - non-iso80369-standardized fluid path protective cover - the proseal priming cap is intended for fluid line priming inside a closed system

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

epic medical pty ltd - 12170 - tubing extension set, intravenous administration - proseal extension sets and/or secondary sets provide an interface for patient administration of drugs and fluids to an iv site in a closed system.