DEVICE DETAILS
| NAME OF DEVICE | WRISTOX2® PULSE OXIMETER |
|---|---|
| ESTABLISHMENT NAME | ACUCARE SYSTEMS (M) SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC7541819-36841 |
| BRAND NAME | NONIN WRISTOX2® |
| MEDICAL DEVICE CATEGORY | MD 1300 - MONITORING DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The Model 3150 is a pulse oximeters with memory for patient data collection and Bluetooth communication capability. The Model 3150 with the use of an external sensor (with a specific cable connection and optional interface cable for Nonin standard sensors) measures the patient's %SpO2 and pulse rate. The unit is small and light weight allowing it to be worn by the patient (writst, upper arm, infant's thigh or bed rail) with the use of an adjustable strap. |
| DEVICE INTENDED PURPOSE | The Nonin Model 3150, WristOx2 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot-checking and/or data collection and recording of adult and pediatric patients, during both no motion and motion conditions, and for patients who are well or poorly perfused. The intended use environments are hospitals, medical facilities, ambulatory, subacute, and sleep study environments and mobile units. |
| VALIDITY DATE OF REGISTRATION | 28/11/2019 - 27/11/2024 |