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DEVICE DETAILS

NAME OF DEVICEMEDISANA PULSE OXIMETER PM 100 CONNECT
ESTABLISHMENT NAMEZUELLIG PHARMA SDN.BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC9976721-74944
BRAND NAMEMEDISANA
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONThe Pulse Oximeter PM 100 CONNECT is a portable non-invasive device used to measure and record the oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of users at any moment. It is a small and compact device which is applicable in the hospital and home use with simple and convenient operation. However, it is reminded that the Pulse Oximeter PM 100 CONNECT is not suitable for continuous blood oxygen monitoring. The measuring range for the SpO2 is 70% to 99% with 1% resolution while the measuring range for the pulse rate is 30 to 235 beats per minute (bpm) with a resolution of 1 bpm.
DEVICE INTENDED PURPOSEThe Pulse Oximeter PM 100 CONNECT is intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate users. It is not suitable for continuous monitoring.
VALIDITY DATE OF REGISTRATION20/09/2021 - 19/09/2026

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1MEDISANA PULSE OXIMETER PM 100 CONNECT48506
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