DEVICE DETAILS
| NAME OF DEVICE | RAD-G PULSE OXIMETER |
|---|---|
| ESTABLISHMENT NAME | NYPRAX BUSINESS SOLUTIONS |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC1159221-57852 |
| BRAND NAME | MASIMO |
| MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | The Rad-G Pulse Oximeter is a rugged, portable, handheld device with a rechargeable battery and LCD display. Leveraging clinically proven Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry technology, Rad-G delivers a high-quality and reliable monitoring solution that empowers clinicians to quickly assess patients and make informed care decisions even in low-resource settings. |
| DEVICE INTENDED PURPOSE | The Rad-GTM Pulse Oximeter 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-GTM Pulse Oximeter 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-GTM Pulse Oximeter 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 | 22/03/2021 - 21/03/2026 |