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DEVICE DETAILS

NAME OF DEVICEFINGERTIP OXIMETER
ESTABLISHMENT NAMERL HEALTHCARE SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC2911422-96742
BRAND NAMECREATIVE MEDICAL
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONFingertip Oximeter Net Weight: 52g Device Dimension: 56x34x30mm Packaging – 1 unit / box; 136unit / carton Net Weight (per carton) – 12kgs Gross Weight (per carton) – 13kgs
DEVICE INTENDED PURPOSEThis Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through a patient’s finger. It is applicable for spot-checking SpO2 and pulse rate of adult and pediatric patients in homes and medical clinics. Models with external sensor options and over-limit Indication may be used for longer periods of time dependent on the suitability of the sensor selected.
VALIDITY DATE OF REGISTRATION04/07/2022 - 03/07/2027

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1FINGERTIP OXIMETERPC-60F
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