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

fresenius medical care australia pty ltd - 58093 - haemodialysis treatment kit - intended for use in the extracorporeal purification of blood in the framework of acute renal failure therapy.

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

fresenius medical care australia pty ltd - 47739 - haemodialysis system dialysate pyrogen filter - dialysis fluid filters are designed for the ultrafiltration of dialysis fluid. the fluid filter removes pyrogens from the dialysate, is located "on-line" in the dialysate fluid path and minimises the risk of pyrogen transfer into the patient's blood.

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

fresenius medical care australia pty ltd - 45815 - dialysis system anticoagulation solution - sodium citrate 4% solution is intended for regional anti-coagulation in continuous renal replacement therapies (crrt) in adults by continuous veno-venous haemodialysis (ci-ca cvvhd)or post-dilution continuous veno-venous haemodiafiltration (ci-ca post cvvhdf). sodium citrate 4% solution is for use only with fmc crrt devices ie multifiltrate & multifitratepro for the cited blood processing therapies, and having integrated pumps to administer the citrate solution as well as calcium. when blood from the extracorporeal circuit is returned to the patient, it mixes with central venous blood which contains calcium that has been continuously administered to the patient, and the anticoagulant effect is neutralized. the solution is typically supplied in a plastic bag with connectors.

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

fresenius medical care australia pty ltd - 58868 - extracorporeal circuit waste bag, non-sterile - a non-sterile flexible container intended to be used for the collection of waste fluids during preparation and processing of an extracorporeal circuit (e.g., haemodialysis, haemofiltration, apheresis), including the collection and rinsing of ultrafiltrate fluid which may contain blood components. the device typically consists of a plastic pouch with a piece of short tubing and a connector (e.g., luer-lock) intended to be connected to the tubing system of the extracorporeal circuit. the contents are considered potentially contaminated and should be disposed of according to local requirements. this is a single-use device.

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

fresenius medical care australia pty ltd - 44903 - blood collection tubing set - a collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells) into containers or between containers for processing or storage. this is a single-use device.

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

fresenius medical care australia pty ltd - 32142 - dialysis start/stop set - to allow the start and stop procedures to be carried out with a patient to perform dialysis.

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

fresenius medical care australia pty ltd - 58093 - haemodialysis treatment kit - heamodialysis treatment kits comprised of various sterile and disposable/consumable devices and medicine intended to be used to prepare and perform haemodialysis treatment with a haemodialysis system. this is a single-use device.

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

fresenius medical care australia pty ltd (nz) - calcium chloride dihydrate 0.1838 g/l; glucose monohydrate 16.5 g/l equivalent to 15 g/l glucose anhydrous;  ; magnesium chloride hexahydrate 0.1017 g/l; sodium chloride 5.64 g/l;  ;  ;  ; sodium lactate 3.925 g/l;   - dialysis solution - active: calcium chloride dihydrate 0.1838 g/l glucose monohydrate 16.5 g/l equivalent to 15 g/l glucose anhydrous   magnesium chloride hexahydrate 0.1017 g/l sodium chloride 5.64 g/l       sodium lactate 3.925 g/l   excipient: hydrochloric acid sodium bicarbonate sodium hydroxide water for injection

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

fresenius medical care australia pty ltd (nz) - calcium chloride dihydrate 0.1838 g/l; glucose monohydrate 16.5 g/l equivalent to 15 g/l glucose anhydrous;  ; magnesium chloride hexahydrate 0.1017 g/l; sodium chloride 5.64 g/l;  ;  ;  ; sodium lactate 3.925 g/l;   - dialysis solution - active: calcium chloride dihydrate 0.1838 g/l glucose monohydrate 16.5 g/l equivalent to 15 g/l glucose anhydrous   magnesium chloride hexahydrate 0.1017 g/l sodium chloride 5.64 g/l       sodium lactate 3.925 g/l   excipient: sodium bicarbonate sodium hydroxide water for injection

New Zealand - engelsk - Medsafe (Medicines Safety Authority)

fresenius medical care australia pty ltd (nz) - calcium chloride dihydrate 0.1838 g/l; glucose monohydrate 46.75 g/l;  ; magnesium chloride hexahydrate 0.1017 g/l; sodium chloride 5.64 g/l;  ;  ;  ; sodium lactate 3.925 g/l;   - dialysis solution - active: calcium chloride dihydrate 0.1838 g/l glucose monohydrate 46.75 g/l   magnesium chloride hexahydrate 0.1017 g/l sodium chloride 5.64 g/l       sodium lactate 3.925 g/l   excipient: hydrochloric acid sodium bicarbonate sodium hydroxide water for injection