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

getinge australia pty ltd - 31715 - sensor, blood gas, cardiopulmonary bypass, in-line - to sense the level of gases in blood during bypass surgery and provide a signal to the measuring unit.

Singapore - English - HSA (Health Sciences Authority)

getinge south east asia pte. ltd. - cardiovascular - maquet permanent life support system is intended for both extracorporeal pulmonary support and cardiovascular support, or for simultaneous cardiovascular and pulmonary support. the rataflow centrifual pump systerm is intended to be used in an extracorporeal perfusion circuit to pump blood during cardiopulmonary bypass interventions and for permanent extracorporeal pulmonary or cardiovascular support. it can be used as a fully independent stand-alone unit or as part of the heart-lung machine. the heater unit hu 35 intended use is to maintain the patient's body temperature during permanent extracorporeal pulmonary or cardiovascular support. it is used in combination of maquet rotaflow system.

Singapore - English - HSA (Health Sciences Authority)

getinge south east asia pte. ltd. - cardiovascular - is intended to monitor blood parameters during cardiopulmonary bypass (cpb) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pao2), temperature (ta and tv), oxygen saturation (svo2), hemoglobin (hb) and hematocrit (hct). oxygen consumption (vo2) can also be calculated. blood flow (qblood) can be entered manually or values can be received from a connected heart-lung machine. the duration of application of the disposable products (arterial bmu sensor and venous bmu cell) is limited to six hours. the bmu 40 is designed for continuous operation.

Singapore - English - HSA (Health Sciences Authority)

getinge south east asia pte. ltd. - cardiovascular - the cardiohelp system is suitable for both extracorporeal pulmonary support and cardiovascular support, and for simultaneous cardiovascular and pulmonary support. the support system is generally suitable for all types of applications as: circulatory support through to recovery, or the temporary bridging of therapeutic measures through to recovery and weaning off the support system; bridging through to explantation/transplantation; temporary bridging through to further therapeutic methods or further decisions; circulatory support to permit further therapeutic and surgical procedures. the cardiohelp system is designed for intra-hospital and inter-hospital patient transport and for continuous operation. the maximum duration of use is 30 days if bioline-coated hls cannulae from maquet are used. if cannulae from other manufacturers are used, the maximum duration of use for the hls set is 6 hours.

Singapore - English - HSA (Health Sciences Authority)

getinge south east asia pte. ltd. - cardiovascular - eka/ekv cannula are used for extracorporeal membrane oxygenation (ecmo) for the treatment of respiratory insufficiency in new-borns.

Singapore - English - HSA (Health Sciences Authority)

getinge south east asia pte. ltd. - cardiovascular - the cannula is used for extracorporeal membrane oxygenation (ecmo) for the treatment of respiratory insufficiency in infants.

Singapore - English - HSA (Health Sciences Authority)

getinge south east asia pte. ltd. - cardiovascular - macquet external temporary pacemakers are for myocardial or transvenous pacing of the heart. the model pace t10 is a single-chamber pacemaker and the model pace t20 is a dual chamber pacemaker. intended for a temporary application ( medical specialty area: cardiovascular medical device class: class c medical device device registration no: de0008706 registration date: 02/03/2012

Singapore - English - HSA (Health Sciences Authority)

getinge south east asia pte. ltd. - cardiovascular - the quadrox-i is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. the venous hardshell reservoir is designed to collect, store and filter the blood in an extracorporeal circuit during cardiopulmonary bypass procedures up to six hours in adult surgery. it can be integrated into almost all perfusion systems.

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

getinge australia pty ltd - 35441 - cardiopulmonary bypass system tubing set - the bioline coated tubing set is designed to be used for transportation of blood and other liquids between the patient and the extracorporeal system maquet's bioline coated tubing sets consisting of tubing, connectors, filters and various other items is designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures.

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

getinge australia pty ltd - 35441 - cardiopulmonary bypass system tubing set - the bioline coated tubing sets are designed to be used for transportation of blood and other liquids between the patient and the extracorporeal system. maquet's bioline coated tubing sets consisting of tubing, connectors, filters and various other items are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures.