DEVICE DETAILS
| NAME OF DEVICE | AVOXIMETER |
|---|---|
| ESTABLISHMENT NAME | STRAITS SCIENTIFIC (M) SDN BHD |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | IVDC6964423-138694 |
| BRAND NAME | ACCRIVA DIAGNOSTICS |
| MEDICAL DEVICE CATEGORY | POINT OF CARE TESTING |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | THE AVOXIMETERS ARE BLOOD GAS SYSTEM THAT MEASURE WHOLE BLOOD BLOOD GAS USING DISPOSABLE SINGLE-USE CUVETTES.AVOXIMETER SYSTEMS HAVE TWO MODELS WHICH ARE AVOXIMETER 1000E AND AVOXIMETER 4000. THEY ARE VARIANT ONLY IN THE THROUGHPUT AND THE READING WAVELENGTH FOR THESE 2 MODELS OF AVOXIMETERS. |
| DEVICE INTENDED PURPOSE | THE AVOXIMETER 1000E IS A BATTERY-OPERATED BEDSIDE WHOLE BLOOD OXIMETER THAT PERFORMS INDIVIDUAL POINT-OF-CARE MEASUREMENTS OF OXYHEMOGLOBIN SATURATION (%HB02) AND TOTAL HEMOGLOBIN CONCENTRATION [THB] ON LITHIUM/SODIUM OR HEPARIN OR EDTA ANTICOAGULATED WHOLE BLOOD SAMPLES. OXYGEN CONTENT [02] OF THE BLOOD SAMPLE IS AUTOMATICALLY CALCULATED FROM THE %HB02 AND THB MEASUREMENTS. THE AVOXIMETER 4000 IS A BATTERY-OPERATED DESKTOP WHOLE BLOOD OXIMETER THAT PERFORMS INDIVIDUAL POINT-OF-CARE MEASUREMENTS OF TOTAL HEMOGLOBIN (THB), OXYHEMOGLOBIN SATURATION (%02HB), CARBOXYHEMOGLOBIN (%COHB), AND METHEMOGLOBIN (%METHB) ON FRESHLY-DRAWN OR HEPARIN- OR EDTA-ANTICOAGULATED WHOLE BLOOD SAMPLES. OXYGEN CONTENT ([02CT]), PERCENT SATURATION (SO2) AND OXYGEN CARRYING CAPACITY (O2CAP) OF THE BLOOD SAMPLE ARE AUTOMATICALLY CALCULATED FROM THE %HB02 AND THB MEASUREMENTS |
| VALIDITY DATE OF REGISTRATION | 06/07/2023 - 05/07/2028 |