DEVICE DETAILS
NAME OF DEVICE | MASIMO RADICAL-7 PULSE CO-OXIMETER |
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ESTABLISHMENT NAME | NYPRAX BUSINESS SOLUTIONS |
REGISTRATION NO | GC3945021-52291 |
BRAND NAME | RADICAL-7 |
DEVICE GROUPING TYPE | SYSTEM |
DEVICE DESCRIPTION | Radical-7 is a noninvasive monitor that measures arterial oxygen saturation (SpO2), pulse rate (PR), and perfusion index (Pi), along with measurements of hemoglobin (SpHb), carboxyhemoglobin (SpCO), total oxygen content (SpOC), methemoglobin (SpMet), Pleth Variability Index (PVi), Acoustic Respiration Rate (RRa), Pleth Respiration Rate (RRp), and Oxygen Reserve Index (ORi). |
DEVICE INTENDED PURPOSE | The Masimo Radical-7 Pulse CO-Oximeter and Accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, carboxyhemoglobin saturation (SpCO), methemoglobin saturation (SpMet), total hemoglobin concentration (SpHb), and/or respiratory rate (RRa) in hospitals, hospital-type facilities, mobile, and home environments. The Masimo Radical-7® Pulse CO-Oximeter® and accessories are indicated for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult, pediatric, and neonatal patients who are well or poorly perfused during both motion and no motion conditions. The Masimo Radical-7® Pulse CO-Oximeter® and accessories are indicated for continuous noninvasive monitoring of methemoglobin (SpMet®) for adult, pediatric, and neonatal patients. The Masimo Radical-7® Pulse CO-Oximeter® and accessories are indicated for continuous noninvasive monitoring of total hemoglobin concentration (SpHb®) for adult and pediatric patients. The Masimo Radical-7® Pulse CO-Oximeter® may be provided with the oxygen reserve index (ORiTM) as an adjunct to standard pulse oximetry monitoring. ORi is a trend index that extends oxygen monitoring to patients on supplemental oxygen in adult and pediatric patients. |
VALIDITY DATE OF REGISTRATION | 13/01/2021 - 12/01/2026 |