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DEVICE DETAILS

NAME OF DEVICERAINBOW PULSE OXIMETER
ESTABLISHMENT NAMENYPRAX BUSINESS SOLUTIONS
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC430321043618
BRAND NAMEMASIMO
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONTHE RADICAL-7 PULSE CO-OXIMETER IS A NONINVASIVE MONITOR 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), OXYGEN RESERVE INDEX (ORI)*, ACOUSTIC RESPIRATION RATE (RRA)*, AND PLETH RESPIRATION RATE (RRP)*.
DEVICE INTENDED PURPOSETHE RADICAL-7 PULSE CO-OXIMETER CAN BE USED AS EITHER A HANDHELD OR A STANDALONE MONITOR. THE RADICAL-7 PULSE CO-OXIMETER FEATURES A TOUCHSCREEN THAT CONTINUOUSLY DISPLAYS NUMERIC VALUES FORARTERIAL 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), OXYGEN RESERVE INDEX (ORI)*, ACOUSTIC RESPIRATION RATE (RRA)*, AND PLETH RESPIRATION RATE (RRP)*.
VALIDITY DATE OF REGISTRATION02/08/2023 - 01/08/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Rad-979738
2Rad-97 NiBP9797
3Rad-97 with Nomoline Capnography9799
4Radical-79500
5Rad-679794
6Pronto Spot Check Pulse CO-Oximeter9167
7Radius-79664
8Rad-57 Configurable Pulse CO-Oximeter9216
9Masimo RainbowSET IntelliVue Module3924
10Root9515
11Root NIBPT9695
12rainbow RC-12, rainbow Patient Cable, 12 ft2404
13rainbow RC-1, rainbow Patient Cable, 1 ft2405
14rainbow RC-4, rainbow Patient Cable, 4 ft2406
15M-LNC-1, M-LNCS Series Patient Cable, 1 ft2523
16M-LNC-4, M-LNCS Series Patient Cable, 4 ft2524
17M-LNC-10, M-LNCS Series Patient Cable, 10 ft2525
18M-LNC-14, M-LNCS Series Patient Cable, 14 ft2526
19M-LNC-10-GE, M-LNCS to GE Patient Cable, 10 ft2533
20M-LNC-04-DB9, M-LNCS to D89 Patient Cable, 4 ft2534
21M-LNC-10-DB9, M-LNCS to DB9 Patient Cable, 10 ft2535
22M-LNC-14-DB9, M-LNCS to DB9 Patient Cable, 14 ft2536
23M-LNC-4-GE, M-LNCS to GE Patient Cable, 4 ft2655
24M-LNC-SL-10, M-LNCS to Spacelab Patient Cable, 10 ft2714
25M-LNC-MP10, M-LNCS to IVM / MMS,10 ft2831
26RC25-12, rainbow Patient Cable, 12 ft3342
27RC25-12RA, rainbow Patient Cable, 12 ft3343
28RC25-4RA, rainbow Patient Cable, 4 ft3375
29M-LNCS Patient Cable, Red M-LNCv-43513
30M-LNCS Patient Cable, Red M-LNCv-103514
31RC25-4, rainbow Patient Cable, 4 ft3628
32M-LNC MP4, M-LNCS to IVM / MMS, 4 ft3754
33RC25-1, rainbow Patient Cable, 1ft3933
34RC25-1RA, Patient Cable, 1ft3934
35M-LNC-10-NK, M-LNCS to NK Patient Cable, 10 ft3985
36rainbow M20-01, rainbow Patient Cable, 1 ft4236
37rainbow M20-04, rainbow Patient Cable, 4 ft4237
38rainbow M20-12, raionbow Patient Cable, 12 ft4238
39rainbow RC-1 EMS, Patient Cable, 1/box4480
40rainbow RC-4 EMS, Patient Cable, 1/box4481
41rainbow RC25-1 EMS, Patient Cable, 1/box4482
42rainbow RC25-4 EMS, Patient Cable, 1/box4483
43rainbow RC25-1RA EMS, Patient Cable, 1/box4484
44rainbow RC25-4RA EMS, Patient Cable, 1/box4485
45spo2.com NRC-180 Patient Cable1810
46spo2.com NRC-395 Patient Cable1811
47spo2.com NRC-P12, Patient Cable1853
48spo2.com NRC-GE Patient Cable1854
49spo2.com NRC-SL , Spacelabs Replacement Cable1900
50spo2.com NRC-P8, Patient Cable, 3M1949
51spo2.com NRC-SL2 Spacelabs Replacement Cable2335
52LNCS Red Patient Cable, Red LNCTM-04, LNCS 20-pin SpO2 Patient Cable, 4 ft., 1/Box2055
53LNCS Red Patient Cable, Red LNCTM-10, LNCS 20-pin SpO2 Patient Cable, 10 ft., 1/Box2056
54LNCS Red Patient Cable, Red LNCTM-14, LNCS 20-pin SpO2 Patient Cable, 14 ft., 1/Box2057
55LNCTM PATIENT CABLE, LNC-4, 4 FT., 1/BOX2017
56LNC PATIENT CABLE, LNC-10, 10 FT., 1/BOX1814
57RD rainbow SET Patient Cable, MD20-1.5, RD rainbow 20-pin Patient Cable, 1.5 ft., 1/Box4071
58RD RAINBOW SET PATIENT CABLE, MD20-05, RD RAINBOW 20-PIN PATIENT CABLE, 5 FT., 1/BOX4072
59RD RAINBOW SET PATIENT CABLE, MD20-08, RD RAINBOW 20-PIN PATIENT CABLE, 8 FT., 1/BOX4109
60RD RAINBOW SET PATIENT CABLE, MD20-12, RD RAINBOW 20-PIN PATIENT CABLE, 12 FT., 1/BOX4073
61RD rainbow SET Patient Cable, 25R-05, RD SET Series, 25-pin Patient Cable, 5 ft., 1/Box 14076
62RD rainbow SET Patient Cable, 25RA-05, RD SET Series, 25-pin Right Angle Patient Cable, 5 ft., 1/Box 14077
63RD rainbow SET Patient Cable, 25R-08, RD SET Series, 25-pin Patient Cable, 8 ft., 1/Box 14106
64RD rainbow SET Patient Cable, 25RA-08, RD SET Series, 25-pin, Right Angle Patient Cable, 8 ft., 1/Box4107
65RD RAINBOW SET PATIENT CABLE, 25R-12, RD SET SERIES, 25-PIN PATIENT CABLE, 12 FT., 1/BOX4078
66RD rainbow SET Patient Cable, 25RA-12, RD SET Series, 25-pin Right Angle Patient Cable, 12 ft., 1/Box4079
67RD SET PATIENT CABLE, MD14-05, 14-PIN RD SET PATIENT CABLE, 5 FT., 1/BOX4080
68RD SETTM Patient Cable, MD14-08, 14-pin RD SETTM Patient Cable, 8 ft., 1/box4108
69RD SET PATIENT CABLE, MD14-12, 14-PIN RD SET PATIENT CABLE, 12 FT., 1/BOX4081
70RD ADAPTER CABLE, RD TO M-LNC ADAPTER CABLE, RD SET SERIES TO M-LNC OR RC PATIENT CABLE, 1.5 FT., 1/BOX4090
71RD ADAPTER CABLE, LNCS TO RD ADAPTER CABLE, LNCS SERIES TO RD PATIENT CABLE, 1 FT., 1/BOX4092
72RD SET PATIENT CABLE, MD20-1.5, 20-PIN PATIENT CABLE, 1.5 FT., 1/BOX4102
73RD SET PATIENT CABLE, MD20-05, 20-PIN PATIENT CABLE, 5 FT., 1/BOX4103
74RD SET PATIENT CABLE, MD20-12, 20-PIN PATIENT CABLE, 12 FT., 1/BOX4104
75RD ADAPTER CABLE, RD TO LNC ADAPTER CABLE, RD SET SERIES TO LNC PATIENT CABLE, 1.5 FT., 1/BOX4105
76RD RAINBOW SET PATIENT CABLE, M20-12, RD RAINBOW M20 CONNECTOR PATIENT CABLE, 12 FT., 1/BOX4257
77RD rainbow SET Patient Cable, M20-05, RD rainbow M20 Connector Patient Cable, 5 ft., 1/Box4256
78RD RAINBOW SET PATIENT CABLE, M20-1.5, RD RAINBOW M20 CONNECTOR PATIENT CABLE, 1.5 FT., 1/BOX4255
79RD SEDLINE PATIENT CABLE, 3 FT., 1/BOX4298
80LNC PATIENT CABLE, LNC-10-GE, LNCS TO GE PATIENT CABLE, 10 FT., 1/BOX2016
81LNCTM Patient Cable, LNC-4-GE, LNCS to GE Patient Cable, 4 ft., 1/Box2430
82LNCS DUAL KEY PATIENT CABLE, LNC MP10, LNCS TO INTELLIVUE MASIMO SET OR INTELLIVUE PHILIPS FAST-SPO2, 10 FT., 1/BOX2281
83LNC PATIENT CABLE, LNC-04-DB9, LNCS TO DB9 CONNECTOR PATIENT CABLE, 4 FT., 1/BOX2285
84RD SETTM Patient Cable, MP-05, RD SETTM to IntelliVue Masimo SET or IntelliVue Philips FAST-SpO2 Dual Key 1 $190.00 Patient Cable, 5 ft., 1/Box4082
85RD SET PATIENT CABLE, MP-12, RD SET TO INTELLIVUE MASIMO SET OR INTELLIVUE PHILIPS FAST-SPO2 DUAL KEY PATIENT CABLE, 12 FT., 1/BOX4083
86RD SETTM Patient Cable, GE-05, RD SETTM to GE Patient Cable, 5 ft., 1/Box4084
87RD SET PATIENT CABLE, GE-12, RD SET TO GE PATIENT CABLE, 12 FT., 1/BOX4085
88RD SET PATIENT CABLE, NK-12, RD SET TO NIHON KOHDEN PATIENT CABLE, 12 FT., 1/BOX4192
89RD SETTM Patient Cable, NK-05, RD SETTM to Nihon Kohden Patient Cable, 5 ft., 1/Box4191
90rainbow RC-EXT-8, Extension Cable, 8 ft., 1/Box3659
91RD rainbow SET RAM Dual Cable MD20-124279
92RD rainbow SET RAM Dual Cable M20-124512
93RD rainbow SET RAM Dual Cable R25-124278
94RAM Dual Cable, LNC-10, 1/Box3661
95RAM Dual Cable LNC M20-10, 1/Box4099
96RAM Dual Cable, Red 25 LNC-10, 1/Box3906
97RAM Dual Cable, RC-10, 1/Box3660
98RAM Dual Cable M20-10, 1/Box4100
99RAM Dual Cable, RC25-10, 1/Box3503
100RD SET Patient Cable, RD SET SL-12, RD SET to SpaceLabs Patient Cable, 12 ft., 1/Box4087
101RD Extension Cable, RD EXT-4, 4 ft., 1/Box4095
102RD Adapter Cable, RD to PC Adapter Cable, RD SET Series to LNOP PC Patient Cable, 1.5 ft., 1/Box4088
103RD Adapter Cable, RD to LNC Adapter Cable, RD SET Series to LNC Patient Cable, 3 ft., 1/Box4089
104RD Adapter Cable, LNOP to RD Adapter Cable, LNOP Series to RD Patient Cable, 1.5 ft., 1/Box4091
105LNCS Red Patient Cable, Red LNC M20-01, LNCS M20 Connector Spot Check Patient Cable, 1 ft., 1/Box4251
106LNCS Red Patient Cable, Red LNC M20-04, LNCS M20 Connector Patient Cable, 4 ft., 1/Box4252
107LNCS Red Patient Cable, Red LNC M20-10, LNCS M20 Connector Patient Cable, 10 ft., 1/Box4253
108LNCS Red Patient Cable, Red LNC M20-14, LNCS M20 Connector Patient Cable, 14 ft., 1/Box4254
109LNCS Red Patient Cable, Red LNCTM-01, LNCS 20-pin SpO2 Spot Check Patient Cable, 1 ft., 1/Box2365
110LNC Patient Cable, LNC-1, 1 ft., 1/Box2364
111LNCS Red Patient Cable, Red 25 LNC-1, LNCS Series 25-pin Patient Cable, 1 ft., 1/Box3935
112LNCS Red Patient Cable, Red 25 LNC-4, 25-pin, 4 ft., 1/Box3630
113LNCS Red Patient Cable, Red 25 LNC-1RA, LNCS Series 25-pin Right Angle Patient Cable, 1 ft., 1/Box3936
114LNCS Red Patient Cable, Red 25 LNC-4RA, 25-pin, 4 ft., 1/Box3376
115LNCS Red Patient Cable, Red 25 LNC-10, 25-pin, 10 ft., 1/Box3345
116LNC Patient Cable, LNC MP4, M-LNCS Dual Key Patient Cable, 4 ft., 1/Box3755
117LNC Patient Cable, LNC-10-DB9, LNCS to DB9 Connector Patient Cable, 10 ft., 1/Box2286
118LNC Patient Cable, LNC-10-NK, LNCS to Nihon Kohden Patient Cable, 10 ft., 1/Box3984
119LNCS Adapter Cable, LNCS Series to LNOP PC Adapter Cable, 18 inch, 1/Box1816
120LNCS Adapter Cable, CMS, LNCS Series to Philips 12-pin Instrument Adapter Cable, 3 m, 1/Box2263
121LNCS Adapter Cable, MAC-GE, LNCS Series to GE Adapter Cable, 3 m, 1/Box2264
122LNCS Adapter Cable, MAC-SL, LNCS Series to Spacelabs Adapter Cable, 3 m, 1/Box2266
123LNCS Adapter Cable, MAC-SL2, LNCS Series to Spacelabs Adapter Cable, 3 m, 1/Box2336
124LNCS Adapter Cable, MAC-180, LNCS Series to N-180 Adapter Cable, 10 ft., 1/Box2268
125LNCS Adapter Cable, MAC-395, LNCS Series to N-395 Adapter Cable, 10 ft., 1/Box2269
126Adapter Cable, 14-pin to 20-pin, Connect PXC2 to Masimo SET 20-pin Devices, SpO2 only, 1/Box2478
127Mountable Extension Cable, PXC2-16, 16 ft., 1/Box2371
128Mountable Extension Cable, PXC2-30, 30 ft., 1/Box2373
129Radical Docking Station, RDS-19021
130Radical Docking Station, RDS-39023
131RD rainbow SET R25-1.54074
132RD rainbow SET RA25-1.54075
133RD rainbow SET MD20-1.5, EMS4791
134RD rainbow SET MD20-04, EMS4792
135RD rainbow SET MD20-12, EMS4793
136RD rainbow SET R25-1.5, EMS4794
137RD rainbow SET R25-04, EMS4795
138RD rainbow SET R25-12, EMS4796
139RD rainbow SET RA25-1.5, EMS4797
140RD rainbow SET RA25-04, EMS4798
141RD rainbow SET RA25-12, EMS4799
142RD SET MD14-1.54675
143RD SET Rad-G-1.54772
144RD SET Rad-G-54773
145RD SET Rad-G-124774
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