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DEVICE DETAILS

NAME OF DEVICEMASIMO O3 REGIONAL OXIMETER SYSTEM
ESTABLISHMENT NAMENYPRAX BUSINESS SOLUTIONS
REGISTRATION NOGC5363421-59812
BRAND NAMEMASIMO
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONThe O3 Regional Oximeter System (O3 System), which consists of the O3 Module and O3 Sensor, is a patient-connected, noninvasive oximeter designed to continuously measure and monitor regional hemoglobin oxygen saturation in the tissue (rSO2). It can be used in any hospital and hospital-type facility where rSO2 measurements might improve patient outcomes.
DEVICE INTENDED PURPOSEThe non-invasive Masimo O3® Regional Oximeter System and accessories are indicated for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood (rSO2) in the cerebral region under the sensors in patients in healthcare environments. The O3 Regional Oximeter is only to be used with Masimo O3 sensors. When used with the O3 Adult Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in adults ≥ 40 kg. When used with the O3 Pediatric Sensor, the O3 Regional Oximeter is indicated for measuring absolute and trending regional hemoglobin oxygen saturation of blood (rSO2) in pediatrics ≥ 5 kg and < 40 kg. When used with the O3 Neonatal Sensor, the O3 Regional Oximeter is indicated for measuring only trending regional hemoglobin oxygen saturation of blood (rSO2) in neonates < 10 kg.
VALIDITY DATE OF REGISTRATION20/04/2021 - 19/04/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1O3 Regional Oximeter 9637
2O3 Sensor3756
3O3 Pediatric Sensor4235
4O3 Infant and Neonatal Sensor4384
5Masimo Root Kit9515