DEVICE DETAILS
NAME OF DEVICE | PULSE OXIMETER |
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ESTABLISHMENT NAME | BEST MADE PHARMACEUTICAL SDN BHD |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GC1470622-89555 |
BRAND NAME | BERRY PULSE OXIMETER |
MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
DEVICE GROUPING TYPE | SINGLE |
DEVICE DESCRIPTION | A Pulse Oximeter is a common device used to check oxygen saturation (SpO2) and pulse rate. It is a small, compact, simple, reliable and durable physiological monitoring device suitable for clinical environments, outpatient departments and the sickroom. It can also be used in the recovery and healthcare organizations as well as the community medical treatments. This product is only intended for adults. Not to be used on children, infants and neonates. |
DEVICE INTENDED PURPOSE | The pulse oximeter is reuse device and intended use for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring. |
VALIDITY DATE OF REGISTRATION | 04/04/2022 - 03/04/2027 |