DEVICE DETAILS
| NAME OF DEVICE | RAD-G PULSE OXIMETER |
|---|---|
| ESTABLISHMENT NAME | NYPRAX BUSINESS SOLUTIONS |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC4950026-231152 |
| BRAND NAME | MASIMO |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The Rad-G® is intended for the noninvasive continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), pleth variability index (PVi®), and pleth respiration rate (RRp®). The following key features are available for Rad-G: • Masimo SET® technology performance. • Noninvasive functional saturation of arterial oxygen hemoglobin (SpO2) and pulse rate (PR), Pleth Variability Index (PVi), and Respiration Rate determined by plethysmographic waveform (RRp). |
| DEVICE INTENDED PURPOSE | The Rad-G® and Accessories are intended for the noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), Pulse Rate (PR), and Pleth Respiration Rate (RRp). The Rad-G® and Accessories are indicated for noninvasive spot-checking or continuous monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate (PR) of adult, pediatric, infant, and neonate patients during both no motion and motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, transport, and home environments. The Rad-G® and Accessories are indicated for the noninvasive spot-checking or continuous monitoring of Respiration Rate from the photoplethysmogram (RRp) of adult and pediatric patients during no motion conditions in hospitals, hospital-type facilities, transport, and home environments. |
| VALIDITY DATE OF REGISTRATION | 17/04/2026 - 16/04/2031 |