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DEVICE DETAILS

NAME OF DEVICEMASIMO PULSE OXIMETER SENSORS
ESTABLISHMENT NAMENYPRAX BUSINESS SOLUTIONS
REGISTRATION NOGC484561060118
BRAND NAMEMASIMO
DESCRIPTIONMASIMO SET SENSORS: THE SERIES OF SENSORS ARE MULTI-WAVELENGTH SENSORS USED TO DISTINGUISH BETWEEN OXYGENATED BLOOD, DEOXYGENATED BLOOD, BLOOD WITH CARBON MONOXIDE, AND BLOOD WITH OXIDIZED HEMOGLOBIN. SIGNAL DATA IS OBTAINED BY PASSING VARIOUS VISIBLE AND INFRARED LIGHTS (7+ LIGHT-EMITTING DIODES (LED%U2019S)) THROUGH A CAPILLARY BED (FOR EXAMPLE, A FINGERTIP, A HAND, A FOOT) AND MEASURING CHANGES IN LIGHT ABSORPTION DURING THE BLOOD PULSATILE CYCLE. THE PHOTODETECTOR RECEIVES THE LIGHT, CONVERTS IT INTO AN ELECTRONIC SIGNAL AND SENDS IT TO THE INSTRUMENT FOR CALCULATION AND DISPLAY OF FUNCTIONAL OXYGEN SATURATION (SPO2), PULSE RATE, FRACTIONAL CONCENTRATIONS OF CARBOXYHEMOGLOBIN (SPCO), METHEMOGLOBIN (SPMET), AND/OR TOTAL HEMOGLOBIN (SPHB), AND/OR FRACTIONAL OXYGEN SATURATION* (SPFO2). THE RAINBOW SERIES OF SENSORS (AND CABLES) ARE INDICATED FOR SPOT-CHECKING AND/OR CONTINUOUS NONINVASIVE MONITORING OF FUNCTIONAL/ARTERIAL OXYGEN SATURATION (SPO2), CARBOXYHEMOGLOBIN SATURATION (SPCO), METHEMOGLOBIN SATURATION OF ARTERIAL HEMOGLOBIN (SPMET), AND/ OR TOTAL HEMOGLOBIN CONCENTRATION (SPHB), AND/OR FRACTIONAL OXYGEN SATURATION (SPFO2), AND OXYGEN CONTENT, AND PULSE RATE, FOR ADULT, PEDIATRIC, INFANT, AND/ OR NEONATAL PATIENTS IN HOSPITALS, HOSPITAL-TYPE FACILITIES, MOBILE, AND HOME ENVIRONMENTS. MASIMO SET SENSORS: THE M-LNCS SERIES OF SPO2 PULSE OXIMETRY SENSORS MEASURE THE LIGHT ABSORPTION OF BLOOD FROM TWO LIGHT EMITTING DIODES (LED%U2019S). OXYGEN SATURATED BLOOD ABSORBS LIGHT DIFFERENTLY AS COMPARED TO UNSATURATED BLOOD. THE AMOUNT OF LIGHT ABSORBED BY THE BLOOD IS USED TO CALCULATE THE RATIO OF OXYGENATED HEMOGLOBIN TO TOTAL HEMOGLOBIN IN ARTERIAL BLOOD.
INTENDED PURPOSETHE SENSORS ARE INDICATED FOR THE CONTINUOUS NON-INVASIVE MONITORING OF ARTERIAL SATURATION (SPO2), ARTERIAL CARBOXYHEMOGLOBIN SATURATION (SPCO®), ARTERIAL METHEMOGLOBIN SATURATION (SPMET®) AND PULSE RATE. THE SENSORS ARE FOR USE WITH INSTRUMENTS CONTAINING MASIMO TECHNOLOGY OR LICENSED TO USE COMPATIBLE SENSORS.
VALIDITY DATE OF REGISTRATION29-06-2018 - 28-06-2023

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1RAS-125, Acoustic Respiration Sensor2759
2RAS-125c, Acoustic Respiration Cloth Sensor3475
3RAS-125c, Short Term Monitoring Acoustic Respiration Cloth Sensor3483
4Rainbow R1 253792
5rainbow R1 203793
6rainbow R1 25L2414
7rainbow R1 20L2415
8rainbow R252221
9rainbow R202222
10rainbow R25-L2219
11rainbow R20-L2220
12LNCS Adtx1859
13LNCS Adtx-32317
14LNCS E12918
15LNCS TFA-12858
16LNCS Red TFA-13857
17LNCS Pdtx1860
18LNCS Pdtx-32318
19LNCS Inf-L1861
20LNCS Neo-L1862
21LNCS NeoPt-L1901
22LNCS Inf2328
23LNCS Inf-32319
24LNCS Neo2329
25LNCS Neo-32320
26LNCS NeoPt2330
27LNCS NeoPt-32321
28LNCS NeoPt-5002331
29LNCS Trauma2411
30LNCS Newborn Neonatal2412
31LNCS Newborn Infant / Pediatrics2413
32M-LNCS Adtx2508
33M-LNCS Adtx-32509
34M-LNCS Pdtx2510
35M-LNCS Pdtx-32511
36M-LNCS E12919
37M-LNCS TFA-13856
38M-LNCS Red TFA-13855
39M-LNCS Inf-L3670
40M-LNCS Neo-L3668
41M-LNCS NeoPt-L3669
42M-LNCS Inf2512
43M-LNCS Inf-32513
44M-LNCS Neo2514
45M-LNCS Neo-32515
46M-LNCS NeoPt2516
47M-LNCS NeoPt-32517
48M-LNCS NeoPt-5002518
49M-LNCS Trauma2521
50M-LNCS Newborn Neonatal2519
51M-LNCS Newborn Infant/Pediatric2520
52M-LNCS Blue2522
53LNOP Adt1001
54LNOP Pdt1025
55LNOP Inf-L1800
56LNOP Neo-L1798
57LNOP NeoPt-L1651
58LNOP Trauma2358
59LNOP Newborn Neonatal2203
60LNOP Newborn Infant/Pediatric2204
61LNOP Blue1970
62RD SET Adt4000
63RD SET Pdt4001
64RD SET Inf 4002
65RD SET Neo4003
66RD SET NeoPt 4004
67RD SET NeoPt-5004005
68RD SET Trauma 4011
69RD SET Newborn Neonatal4013
70RD SET Newborn I/P4012
71RD Rainbow SET-2 Adt4026
72RD Rainbow SET-2 Pdt4027
73RD Rainbow SET-2 Inf4028
74RD Rainbow SET-2 Neo4029
75RD Rainbow SET-3 Adt4030
76RD Rainbow SET-3 Pdt4031
77RD Rainbow SET-3 Inf4032
78RD Rainbow SET-3 Neo4033
79RD Rainbow Lite SET-1 Adt4042
80RD Rainbow Lite SET-1 Paed4043
81RD Rainbow Lite SET-1 Inf4044
82RD Rainbow Lite SET-1 Neo4045
83Ras-45, Acoustic Respiration 4171
84O3 regional Oximetry, Adult3756
85O3 regional Oximetry, Paed4235
86RD SedLine Sensor4248
87rainbow ReSposable R2-25 Sensor System3457
88rainbow ReSposable R2-20 Sensor System3458
89rainbow ReSposable R2-25r Sensors3395
90rainbow ReSposable R2-20r Sensors3411
91rainbow ReSposable™R2-25a Sensors2753
92rainbow ReSposable™ R2-20a Sensors2755
93rainbow DCI SC 2003418
94rainbow DCIP SC 2003419
95rainbow DCI SC 4003420
96rainbow DCIP SC 4003421
97rainbow DCI SC 10003647
98rainbow DCIP SC 10003648
99rainbow DCI-mini SC 2003797
100rainbow DCI-mini SC 4003798
101rainbow DCI-mini SC 10003799
102rainbow 4D DC Sensor, Small9400
103rainbow 4D DC Sensor, Medium9401
104rainbow 4D DC Sensor, Large9402
105rainbow DCI2696
106rainbow DCIP2697
107rainbow DCI-63657
108rainbow DCIP-63658
109rainbow DCI-dc32201
110rainbow DCIP-dc32069
111LNCS DCI1863
112LNCS DCIP1864
113LNCS DBI2853
114LNCS TC-I1895
115LNCS Y-I2258
116LNCS TF-I1896
117M-LNCS DCI2501
118M-LNCS DCIP2502
119M-LNCS DBI2507
120M-LNCS TC-I2503
121M-LNCS Y-I2505
122M-LNCS TF-I2504
123LNOP DCI1269
124LNOP DCIP1276
125LNOP TC-I1794
126LNOP TF-I1793
127LNOP DC-1951560
128LNOP Y-I1544
129DCSC1396
130DB-I-dc32651
131Red DCI-dc32053
132Red DCIP-dc32256
133Red DBI-dc32643
134LNCS DBI SpO22653
135RD SET DCI4050
136RD SET DCI-P4051
137RD SET YI4054
138Rainbow Super DCI-mini Lite SC 2004309
139Rainbow Super DCI-mini Lite SC 4004310
140Rainbow Super DCI-mini Lite SC 10004311
141RD SET Tip Clip4053
142O3 Infant and Neonatal Sensor4384
143RD SET TFA-1 Adult / Pediatric SpO2 disposable tranflectance forehead sensor, 3 ft4016
144RD SET Blue Neonatal / Infant / Pediatric SpO2 Adhesive Sensor4014
145RD SET E1 Adult SpO2, Disposable Ear Sensor, 3ft4015
146RD SET DBI Adult Soft Reusable Sensor, 3ft4052
147RD SET Adt CS-2 Adult SpO2 Adhesive Sensor, 2ft4470
148RD SET Pft CS-2 Pediatric SpO2 Adhesive Sensor, 2ft4471
149RD SET Inf CS-2 Infant SpO2 Adhesive Sensor, 2ft4472
150RD SET Neo CS-2 Adult / Neonatal SpO2 Adhesive Sensor, 2ft4473
151RD SET NeoPt CS-2 Neonatal SpO2 Adhesive Sensor, 2ft4474
152RD SET Adt CS-3 Adult SpO2 Adhesive Sensor, 3ft4475
153RD SET Pdt CS-3 Pediatric SpO2 Adhesive Sensor, 3ft4476
154RD SET Neo CS-3 Adult / Neonatal SpO2 Adhesive Sensor, 3ft4477
155RD SET Neo CS-3 Adult / Neonatal SpO2 Adhesive Sensor, 3ft4478
156RD SET NeoPt CS-3 Neonatal SpO2 Adhesive Sensor, 3ft4479
157RD SET™ TF-14055
158RD SedLine EEG Sensor, Adult4248
159RD SedLine EEG Sensor, Pediatric4329
160Rainbow DCIP-dc12, Pediatric Reusable, 12 ft. 1/box, (SpO2, SpCO, SpMet)2070
161Rainbow DCI-dc12, Adult Reusable Direct Connect Sensor, 12 ft, 1/box (SpO2, SpCO, SpMet)2202
162Rainbow DC-3 SC-360, Adult Reusable Sensor, 3 ft, 1/box (SpO2, SpHb), 360 Spot checks2241
163Rainbow DC-12 SC-360, Adult Reusable Sensor, 12 ft, 1/box (SpO2, SpHb), 360 Spot checks2242
164Rainbow Adult Sample Pack, 1-Rainbow R25 and 1-Rainbow R25-L Sensor SpO2, SpCO, SpMet Sensors2291
165Rainbow Ped/Inf Sample Pack, 1 Rainbow R20 and 1 Rainbow R20-L Sensor SpO2, SpCO, SpMet Sensors2292
166Rainbow DCI SC-360, Adult Reusable Sensor, 3 ft, 1/box (SpO2, SpHb), 360 Spot checks2333
167Rainbow DCIP SC-360, Pediatric Reusable Sensor, 3 ft, 1/box (SpO2, SpHb), 360 Spot checks2334
168Rainbow DCP-3 SC-360, Pediatric Reusable Sensor, 3 ft. 1/box, (SpO2, SpHb), 360 Spot checks2402
169Rainbow DCP-12 SC-360, Pediatric Reusable Sensor, 12 ft. 1/box, (SpO2, SpHb), 360 Spot checks2403
170Rainbow DCI-dc8, Adult Reusable Direct Connect Sensor, 8 ft, 1/box (SpO2, SpCO, SpMet)2407
171Rainbow R1 25, Adult Adhesive Sensors (SpO2, SpHb, SpMet), 10/box2416
172Rainbow R1 20, Pediatric Adhesive Sensors (SpO2, SpHb, SpMet), 10/box2417
173Rainbow R1 25 Adult Demo Pack, 2 Rainbow R1 25 SpHb, SpO2, SpMet Sensors2625
174Rainbow R1 20 Ped Demo Pack, 2 Rainbow R1 20 SpHb, SpO2, SpMet Sensors2626
175Rainbow DCIP-dc8, Pediatric Reusable, 8ft, 1/box (SpO2, SpCO, SpMet)2640
176Rainbow DC-3 SC-200, Adult Reusable Sensor, 3 ft, 1/box (SpO2, SpHb), 200 Spot checks2646
177Rainbow DCP-3 SC-200, Pediatric Reusable Sensor, 3 ft, 1/box (SpO2, SpHb), 200 Spot checks2647
178Rainbow R1 25L Adult Demo Pack, 2 Rainbow R1 25L SpHb, SpO2, SpMet Sensors2745
179Rainbow R1 20L Inf Demo Pack, 2 Rainbow R1 20L SpHb, SpO2, SpMet Sensors2746
180Rainbow ReSposable R2-25r, Adult Reusable Sensors, SpO2, SpHb & SpMet (5/box)2754
181Rainbow ReSposable R2-20r, Pediatric Reusable Sensors, SpO2, SpHb & SpMet (5/box)2756
182Rainbow 4D DC SC-500, 500 Spot Check Sensor, SpHb, SpO2, PR, PI2953
183Rainbow 4D DC SC-1000, 1000 Spot Check Sensor, SpHb, SpO2, PR, PI2954
184RAS-45 Inf/Neo, Acoustic Respiration Sensor, 3ft4425
185SpO2.com A, Adult Adhesive Sensors, 24/Box1774
186SpO2.com P, Pediatric Adhesive Sensors, 24/Box1775
187SpO2.com, Infant Adhesive Sensors, 24/Box1777
188SpO2.com, Neonatal Adhesive Sensors, 24/Box1176