DEVICE DETAILS
| NAME OF DEVICE | YONKER FINGERTIP PULSE OXIMETER |
|---|---|
| ESTABLISHMENT NAME | CAREFORCE MEDICARE SUPPLIES SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC4998120-43555 |
| BRAND NAME | YONKER FINGERTIP PULSE OXIMETER |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The Fingertip Pulse Oximeter is a kind of innovative medical device with non invasive and continuous features for arterial SPO2 and PR detection. It can be used to measure human hemoglobin saturation and heart rate through finger. The product can be applied in family, hospital (including clinical use in internist surgery, anesthesia, pediatrics, intensive care , etc.), oxygen clubs , social medical organizations, physical care in sports ( it can be used before or after sports. Operation during sport process is not recommended). It is also applicable to athletes, mountaineering enthusiasts, elders over 60 , patients (convalescents at home or those who need first aid treatment), those who work more than 12 hours per day , and those work in the hermetic circumstance, etc. |
| DEVICE INTENDED PURPOSE | The Fingertip Pulse Oximeter are intended use to measure blood oxygen saturation and pulse in medical institute (Not applicable to ICU) or at household. The fingertip Pulse Oximeter can be used to measure human hemoglobin saturation and heart rate through finger. The product applies to use in family, hospital (including clinical use in internist/surgery, anesthesia, pediatrics, intensive care, etc.), oxygen club, social medical organizations, physical care in sports (It can be used before or after sports. Operation in sport procedure is not recommended). It is also applicable to enthusiasts on mountaineering, patients (convalescents at home or those need first aid treatment), elders over 60, those work more than 12 hours, spotters and those work in the hermetic circumstance, etc. The product is not suitable to monitor patient continuously. |
| VALIDITY DATE OF REGISTRATION | 01/06/2020 - 31/05/2025 |