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

draeger australia pty ltd - 35457 - nebulizer, non-heated - pneumatic medication nebulizer for administering medication aerosols in the inspiratory gas during automatic ventilation. the medical device is tested for system compatibility and released for use with specific main devices, e.g., babylog 8000 and babylog vn500 (component of iacs workstation neonatal care).

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

draeger australia pty ltd - 14361 - ventilator, neonatal/paediatric - the intensive care ventilator babylog is intended for the ventilation of neonates from 0.4 kg (0.88 lb) up to 10 kg (22 lb), and pediatric patients from 5 kg (11 lb) up to 20 kg (44 lb) bodyweight. this device provides mandatory ventilation modes and ventilation modes for supporting spontaneous breathing as well as ventilation monitoring.

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

draeger australia pty ltd - 35202 - cannula, nasal, continuous positive airway pressure - ventilation accessory for using nasal cpap (continuous positive airway pressure) with drager babylog neonatal ventilators. for the treatment of premature babies and newborn with sufficient spontaneous breathing when supported with a nasal cpap at a maximum flow rate of 15l/min

Singapore - English - HSA (Health Sciences Authority)

draeger singapore pte ltd - anaesthesiology - babyflow® is an accessory for using nasal cpap with the following ventilators: (1) evitaxl from software version 6.0 with neoflow and niv options (2) evita 4/evita 4 edition from software version 4.20 with neoflow and niv options (3) evita 2 dura from software version 4.20 with neoflow and niv options (4) babylog 8000 (5) babylog 8000 sc (6) babylog 8000 plus (7) babylog 2000 (babyflow disposable only).

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac1600 is intended to acquire, analyze, display and record information from adult and pediatric populations. pediatric population is defined as patients between the ages of 0 and 15 years. the mac1600 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ecg signals from surface electrodes. the mac1600 is used under the direct supervision of a licensed healthcare practitioner. the mac 1600 is not designed to provide alarms for arrhythmia detection. the device is not suitable for intra cardiac application. it is not intended for use as a vital signs physiological monitor or for use during patient transport.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac 3500 ecg analysis system is intended to acquire, analyze, display and record testing electrocardiographic information from adult and pediatric populations. basic systems deliver 3,6,12 or 15 lead ecgs, including interpretive analysis. transmission and reception of ecg data to and from a central ecg cardiovascular information system is optional. the mac 3500 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac 5500hd ecg analysis system is intended to acquire, analyze, display, and record electrocardiographic information adult and pediatric populations. basic systems deliver 3, 6, 12, or 15 lead ecg’s, interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of qrs and p wave portions of the electrocardiogram. transmission and reception of ecg data to and from a central ecg cardiovascular information system is optional. the mac 5500hd is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional’s facility.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - the mac 600 resting ecg analysis system is intended to acquire, analyze, display, and record electrocardiographic information for adult and pediatric populations. basic systems deliver 3 or 12 lead ecgs, and can be upgraded to provide software analysis options such as interpretive analysis of the electrocardiogram. transmission of ecg data to a central ecg cardiovascular information system is optional. the mac 600 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

Singapore - English - HSA (Health Sciences Authority)

ge healthcare pte. ltd. - cardiovascular - 1. maci is intended to be an ecg acquisition, analysis and recording system. 2. maci is intended for use under the direct supervision of a licensed healthcare practitioner. 3. trained operators in small and medium hospitals will use maci to record ecg signals from surface electrodes. 4. maci is intended to acquire, record and measure electrocardiogram information from adult and pediatric populations. 5. the basic system delivers 12 leads ecg in print. 6. maci is not intended for use as a vital signs physiological monitor. 7. maci is not intended for use during patient transport. 8. maci is not intended for intra cardiac application.

Singapore - English - HSA (Health Sciences Authority)

draeger singapore pte ltd - cardiovascular - the monitors are capable of monitoring: heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, apnea, st segment analysis, 12-lead st segment analysis, tcpo2/tcpco2, eeg signals, fio2 and end tidal co2. scio gas module sampled breathing gases from adults and pediatrics. the gas module continuously measures the content of co2, n2o, o2 and one of the anesthetic agents, halothane, isoflurane, enflurane, sevoflurane and desflurane in any mixture and communicates real time and derived gas information to the infinity monitors. the devices are intended for use in the adult, pediatric and neonatal populations, with the exception of the parameter cardiac output, st segment analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpo2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.