DEVICE DETAILS
NAME OF DEVICE | PULSE OXIMETER |
---|---|
ESTABLISHMENT NAME | REVO HEALTHCARE SDN BHD |
ROLE OF ESTABLISHMENT | MANUFACTURER |
REGISTRATION NO | GC3365525-210246 |
BRAND NAME | NOVOPLUS NEUW |
MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
DEVICE GROUPING TYPE | SINGLE |
DEVICE DESCRIPTION | The NovoPlus Neuw Pulse Oximeter (model: PO77A) is a small, portable, non-invasive, easy-to-use, handheld device that displays oxygen saturation levels and pulse rate. Its specifications include an oxygen saturation measurement range of 0% to 100% and a pulse rate measurement range of 25 bpm to 250 bpm. The PO77A pulse oximeter consists of a probe, electronic circuits, a plastic enclosure, a compartment for battery placement, and a display that shows various information, including the oxygen saturation level, oxygen saturation symbol, low battery indicator, pulse rate, plethysmogram, and more. The device is powered by two AAA alkaline batteries, and it emits a sound when blood oxygen falls below or pulse rate exceeds the set threshold. |
DEVICE INTENDED PURPOSE | The NovoPlus Neuw Pulse Oximeter is a reusable device and is intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients. |
VALIDITY DATE OF REGISTRATION | 02/09/2025 - 01/09/2030 |