Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

fresenius medical care deutschland gmbh - sodium hydrogen carbonate 3,36 mg/ml; sodium chloride 5,5 mg/ml; calcium chloride dihydrate 0,18 mg/ml; glucose monohydrate - eq. glucose 42,5 mg/ml; magnesium chloride hexahydrate 0,1017 mg/ml - solution for peritoneal dialysis - hypertonic solutions

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

fresenius medical care deutschland gmbh - sodium hydrogen carbonate 3,36 mg/ml; sodium chloride 5,5 mg/ml; calcium chloride dihydrate 0,18 mg/ml; glucose monohydrate - eq. glucose 42,5 mg/ml; magnesium chloride hexahydrate 0,1017 mg/ml - solution for peritoneal dialysis - hypertonic solutions

Singapore - English - HSA (Health Sciences Authority)

livanova singapore pte ltd - cardiovascular - the heater-cooler is used with a stockert heart-lung machine (s3/sc) for the controlled heating/cooling of 3 water circuits during extracorporeal perfusion. the water circuits are used for cooling/heating blood (in the oxygenator), hypothermia blankets or cardioplegic solutions.

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

livanova australia pty ltd - 38473 - information system, patient record - the essenz patient monitor is intended to perform, control, monitor and support extracorporeal blood circulation replacing the mechanical pumping function of the heart, monitoring and regulating physiologic parameters during procedures requiring extracorporeal circulation.

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

livanova australia pty ltd -

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

livanova australia pty ltd -

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

livanova australia pty ltd - 34893 - cannula, arterial - arterial cannula for placement in the aortic arch or major arterial vessels to deliver the oxygenated blood from heart lung machine into the circulatory system of the patient. the straight tip with collar is for suturing and without wire reinforcement for flexibility. intended to deliver the oxygenated blood from the heart lung machine into the circulatory system of the patient.

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

livanova australia pty ltd - 34893 - cannula, arterial - arterial cannula for placement into the ascending aorta or the major arterial vessels in order to deliver the oxygenated blood from heart lung machine into the circulatory system of a paediatric patient. the bent tip terminating with a collar for suturing and with wire reinforcement to prevent kinking. intended to deliver the oxygenated blood from the heart lung machine into the circulatory system of the paediatric patient

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

livanova australia pty ltd - 34893 - cannula, arterial - arterial cannula for placement in aortic arch with a bent tip terminating with a collar for suturing and with wire reinforcement. intended to deliver the oxygenated blood from the heart lung machine into the circulatory system of a paediatric patient.

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

livanova australia pty ltd - 35338 - adaptor, shunt - a connecting device used to join the tubing to other devices in order to make them compatible so they mate together