This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


DEVICE DETAILS

NAME OF DEVICERAINBOW PULSE OXIMETER
ESTABLISHMENT NAMENYPRAX BUSINESS SOLUTIONS
REGISTRATION NOGC430321043618
BRAND NAMEMASIMO
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 REGISTRATION29/06/2018 - 28/06/2023

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Rad-979738
2Rad-97 NiBP9797
3Rad-97 with Nomoline Capnography9799
4Radical-79500
5Radical Docking Station, RDS-19021
6Radical Docking Station, RDS-39023
7Rad-679794
8Pronto Spot Check Pulse CO-Oximeter9167
9Radius-79664
10Rad-57 Configurable Pulse CO-Oximeter9216
11Masimo RainbowSET IntelliVue Module3924
12Root9515
13Root NIBPT9695
14rainbow RC-12, rainbow Patient Cable, 12 ft2404
15rainbow RC-1, rainbow Patient Cable, 1 ft2405
16rainbow RC-4, rainbow Patient Cable, 4 ft2406
17M-LNC-1, M-LNCS Series Patient Cable, 1 ft2523
18M-LNC-4, M-LNCS Series Patient Cable, 4 ft2524
19M-LNC-10, M-LNCS Series Patient Cable, 10 ft2525
20M-LNC-14, M-LNCS Series Patient Cable, 14 ft2526
21M-LNC-10-GE, M-LNCS to GE Patient Cable, 10 ft2533
22M-LNC-04-DB9, M-LNCS to D89 Patient Cable, 4 ft2534
23M-LNC-10-DB9, M-LNCS to DB9 Patient Cable, 10 ft2535
24M-LNC-14-DB9, M-LNCS to DB9 Patient Cable, 14 ft2536
25M-LNC-4-GE, M-LNCS to GE Patient Cable, 4 ft2655
26M-LNC-SL-10, M-LNCS to Spacelab Patient Cable, 10 ft2714
27M-LNC-MP10, M-LNCS to IVM / MMS,10 ft2831
28RC25-12, rainbow Patient Cable, 12 ft3342
29RC25-12RA, rainbow Patient Cable, 12 ft3343
30RC25-4RA, rainbow Patient Cable, 4 ft3375
31M-LNCS Patient Cable, Red M-LNCv-4 3513
32M-LNCS Patient Cable, Red M-LNCv-10 3514
33RC25-4, rainbow Patient Cable, 4 ft3628
34M-LNC MP4, M-LNCS to IVM / MMS, 4 ft3754
35RC25-1, rainbow Patient Cable, 1ft3933
36RC25-1RA, Patient Cable, 1ft3934
37M-LNC-10-NK, M-LNCS to NK Patient Cable, 10 ft3985
38rainbow M20-01, rainbow Patient Cable, 1 ft4236
39rainbow M20-04, rainbow Patient Cable, 4 ft4237
40rainbow M20-12, raionbow Patient Cable, 12 ft4238
41rainbow RC-1 EMS, Patient Cable, 1/box4480
42rainbow RC-4 EMS, Patient Cable, 1/box4481
43rainbow RC25-1 EMS, Patient Cable, 1/box4482
44rainbow RC25-4 EMS, Patient Cable, 1/box4483
45rainbow RC25-1RA EMS, Patient Cable, 1/box4484
46rainbow RC25-4RA EMS, Patient Cable, 1/box4485
47spo2.com NRC-180 Patient Cable 1810
48spo2.com NRC-395 Patient Cable 1811
49spo2.com NRC-P12, Patient Cable 1853
50spo2.com NRC-GE Patient Cable 1854
51spo2.com NRC-SL , Spacelabs Replacement Cable 1900
52spo2.com NRC-P8, Patient Cable, 3M1949
53spo2.com NRC-SL2 Spacelabs Replacement Cable 2335