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DEVICE DETAILS

NAME OF DEVICEMASIMO OXIMETER SYSTEM
ESTABLISHMENT NAMENYPRAX BUSINESS SOLUTIONS
REGISTRATION NOGC65021962818
BRAND NAMEMASIMO
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONTHE MASIMO PULSE CO-OXIMETER, IS A NONINVASIVE, PATIENT MONITORING DEVICE THAT MEASURES ARTERIAL OXYGEN SATURATION (SPO2), PULSE RATE (PR), AND PERFUSION INDEX (PI), ALONG WITH OPTIONAL MEASUREMENTS OF HEMOGLOBIN (SPHB), CARBOXYHEMOGLOBIN (SPCO), TOTAL OXYGEN CONTENT (SPOC), METHEMOGLOBIN (SPMET), PLETH VARIABILITY INDEX (PVI), ACOUSTIC RESPIRATION RATE (RRA), PLETH RESPIRATION RATE (RRP)
DEVICE INTENDED PURPOSETHE MASIMO PULSE CO-OXIMETER AND ACCESSORIES ARE INDICATED FOR THE CONTINUOUS NONINVASIVE 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 (RRA).
VALIDITY DATE OF REGISTRATION12/06/2018 - 11/06/2023

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Rad-8, Horizontal9190
2Rad-8, Vertical9191
3Rad-5 Pulse Oximeter9196
4Rad-5 ulse Oximeter with Sample Pack9198
5Rad-5 Pulse Oximeter (International Only)9214
6Rad-5v Pulse Oximeter9197
7Rad-5v Pulse Oximeter with Sample Pack9199
8Rad-5v Pulse Oximeter 9International Only)9215
9Radical-7 Handheld9500
10Radical Docking Station, RDS-19021
11Radical Docking Station, RDS-39023
12Rad-87, Horizontal9226
13Rad-87, Vertical 9228
14Pronto-7 Spot Check Pulse CO-Oximeter 9221
15Pronto Spot Check Pulse CO-Oximeter9167
16Rad-57 Configurable Pulse CO-Oximeter9216
17Root9515
18Masimo SET IntelliVue Module 2267
19Masimo SET VueLink Module1881
20iSpO2 Rx 30 pin series, Adult3588
21iSpO2 Rx 30 pin series, Pediatric3590
22iSpO2 Rx 30 pin series, M-LNCS3721
23iSpO2 Rx Lightning series, Adult9575
24iSpO2 Rx Lightning series, Pediatric9576
25iSpO2 Rx Lightning series, M-LNCS9569
26iSpO2 Rx Micro USB series Adult9578
27iSpO2 Rx Micro USB series Pediatric 9579
28iSpO2 Rx Micro USB series M-LNCS9577
29iSpO2 Rx App(iOS)24715
30iSpO2 Rx (Android)24717
31Safety net9095
32Radius-79664
33MightySat Rx Fingertip Pulse Oximeter, non bluetooth (for professional use)9707
34MightySat Rx Fingertip Pulse Oximeter, bluetooth (for professional use)9807
35MightySat Rx, fingertip pulse oximeter, bluetooth and PVI (for professional use)9907
36MightySat, fingertip pulse oximeter, non-bluetooth (for personal use)9701
37MightySat, fingertip pulse oximeter, bluetooth (for personal use)9801
38MightySat, fingertip pulse oximeter, bluetooth and PVI (for personal use)9901
39O3 Module9637
40O3 Sensor3756
41Root NIBP9695