DEVICE DETAILS
| NAME OF DEVICE | HAND HELD PULSE OXIMETER WITH SPO2 PROBE SENSOR |
|---|---|
| ESTABLISHMENT NAME | GASWORLD SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC16137237017 |
| BRAND NAME | ACARE |
| MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | SYSTEM |
| DEVICE DESCRIPTION | AH-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. |
| DEVICE INTENDED PURPOSE | THE 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 REGISTRATION | 02/06/2017 - 01/06/2022 |