DEVICE DETAILS
| NAME OF DEVICE | MASIMO RAD-97 PULSE CO-OXIMETER |
|---|---|
| ESTABLISHMENT NAME | NYPRAX BUSINESS SOLUTIONS |
| REGISTRATION NO | GC7505721-58612 |
| BRAND NAME | MASIMO |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The Rad-97 Pulse CO-Oximeter is a non-invasive device intended to monitor functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), perfusion index (Pi), and Pleth Variability Index (PVi) along with optional non-invasive measurements of total hemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), Acoustic Respiration Rate (RRa), Oxygen Reserve Index (ORi) and Pleth Respiration Rate (RRp). |
| DEVICE INTENDED PURPOSE | The Masimo Rad-97 and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RR). The Masimo Rad-97 and accessories are indicated for use with adult, pediatric, and neonatal patients during both no motion and motion conditions, and for patients who are well or poorly perfused. In addition, the Masimo Rad-97 and Accessories are indicated to provide the continuous non-invasive monitoring data obtained from the Masimo Rad-97 and Accessories for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) to multi-parameter devices for the display on those devices. |
| VALIDITY DATE OF REGISTRATION | 31/03/2021 - 30/03/2026 |