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DEVICE DETAILS

NAME OF DEVICEHAND HELD PULSE OXIMETER WITH SPO2 PROBE SENSOR
ESTABLISHMENT NAMEGASWORLD SDN BHD
REGISTRATION NOGC16137237017
BRAND NAMEACARE
DESCRIPTIONAH-MX PULSE OXIMETER IS A HIGH QUALITY AND WELL-FUNCTIONED DEVICE TO CHECK PATIENT’S BLOOD OXYGEN SATURATION (SPO2) LEVEL AND PULSE RATE. AS A PORTABLE, CONVENIENT AND RELIABLE PHYSIOLOGICAL MONITORING DEVICE, HANDHELD PULSE OXIMETER AH-MX CAN GREATLY ENHANCES PATIENT CARE. THE AH-M1 HANDHELD PULSE OXIMETER IS INTENDED FOR CONTINUOUSLY MONITORING OR SPOT CHECKING PERIPHERAL OXYGEN SATURATION (SPO2) AND PULSE RATE (PR) FOR ADULT, PEDIATRIC OR NEONATAL PATIENTS. THIS DEVICE CAN BE USED IN INSTITUTIONS OR UNITS WITH HEALTHCARE CAPABILITY. THIS INCLUDES OUTPATIENT DEPARTMENTS, EMERGENCY ROOMS AND DEPARTMENTS OF INTERNAL MEDICINE IN HOSPITALS, ORDINARY DEPARTMENTS IN CLINICS, NURSING HOSPITALS AND COMMUNITY MEDICAL INSTITUTIONS. IT MAY ALSO BE USED IN THE HOME.
INTENDED PURPOSETHE AH-MX SERIES PULSE OXIMETER IS INTENDED FOR MEASURING AND DISPLAYING FUNCTIONAL OXYGEN SATURATION OF ARTERIAL HEMOGLOBIN (SPO2) AND PULSE RATE FOR ADULT, PEDIATRIC IN FAMILY, HOSPITAL (INCLUDING CLINICAL USE IN INTERNIST/SURGERY, ANESTHESIA, INTENSIVE CARE AND ETC.), OXYGEN BAR, SOCIAL MEDICAL ORGANIZATIONS, PHYSICAL CARE IN SPORTS(IT CAN BE USED BEFORE OR AFTER SPORTS. CONTINUOUSLY MONITORING IS NOT RECOMMENDED.)
VALIDITY DATE OF REGISTRATION02-06-2017 - 01-06-2022

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Handheld Pulse OximeterAH-MX
2 SPO2 Probe SensorASANR-D1
3 SPO2 Probe SensorASSNR-D1
4SPO2 Probe SensorASPNR-D1
5SPO2 Probe SensorASYNR-D1
6SPO2 Probe SensorASDNR-N3
7SPO2 Probe SensorASANR-D1
8SPO2 Probe SensorASSNR-D1
9SPO2 Probe SensorASPNR-D1
10SPO2 Probe SensorASYNR-D1