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DEVICE DETAILS

NAME OF DEVICEMASIMO RADICAL-7 PULSE CO-OXIMETER
ESTABLISHMENT NAMENYPRAX BUSINESS SOLUTIONS
REGISTRATION NOGC3945021-52291
BRAND NAMERADICAL-7
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONRadical-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 PURPOSEThe 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 REGISTRATION13/01/2021 - 12/01/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Radical-7 Pulse CO-Oximeter9500
2Root9515
3Radical Docking Station-39023
4Radical Docking Station-19021
5RD SET Blue Neonatal / Infant / Pediatric SpO2 Adhesive Sensor4014
6RD SET™ E1® SpO2 Adult Single-Patient Use Ear Sensor4015
7RD SET™ TFA-1® Adult / Pediatric SpO2 Disposable Tranflectance Sensor4016
8RD SET™ DBI SpO2 Adult Soft Reusable Sensor4052
9RD SET™ Adt cs-2 Adult Pulse Oximeter Adhesive Sensor4470
10RD SET™ Pdt cs-2 Pediatric Pulse Oximeter Adhesive Sensor4471
11RD SET™ Inf cs-2 Infant Pulse Oximeter Adhesive Sensor4472
12RD SET™ Neo cs-2 Neonatal/Adult Pulse Oximeter Adhesive Sensor4473
13RD SET™ NeoPt cs-2 Neonatal Pulse Oximeter Adhesive Sensor4474
14RD SET™ Adt cs-3 Adult Pulse Oximeter Adhesive Sensor4475
15RD SET™ Pdt cs-3 Pediatric Pulse Oximeter Adhesive Sensor4476
16RD SET™ Inf cs-3 Infant Pulse Oximeter Adhesive Sensor4477
17RD SET™ Neo cs-3 Neonatal/Adult Pulse Oximeter Adhesive Sensor4478
18RD SET™ NeoPt cs-3 Neonatal Pulse Oximeter Adhesive Sensor4479
19Rainbow DCI SC1000 Adult reusable sensor3647
20Rainbow DCI-P SC 1000 Pediatric reusable sensor3648
21Rainbow DCI-6 Adult reusable sensor3657
22Rainbow DCI-P-6 Pediatric reusable sensor3658
23RAS-45 Inf/Neo Acoustic Respiration Sensor4425