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DEVICE DETAILS

NAME OF DEVICEWRISTOX2® PULSE OXIMETER
ESTABLISHMENT NAMEACUCARE SYSTEMS (M) SDN BHD
REGISTRATION NOGC7541819-36841
BRAND NAMENONIN WRISTOX2®
DESCRIPTIONThe Model 3150 is a pulse oximeters with memory for patient data collection and Bluetooth communication capability. The Model 3150 with the use of an external sensor (with a specific cable connection and optional interface cable for Nonin standard sensors) measures the patient's %SpO2 and pulse rate. The unit is small and light weight allowing it to be worn by the patient (writst, upper arm, infant's thigh or bed rail) with the use of an adjustable strap.
INTENDED PURPOSEThe Nonin Model 3150, WristOx2 Pulse Oximeter is a small, wrist-worn device indicated for use in measuring, displaying and storing functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot-checking and/or data collection and recording of adult and pediatric patients, during both no motion and motion conditions, and for patients who are well or poorly perfused. The intended use environments are hospitals, medical facilities, ambulatory, subacute, and sleep study environments and mobile units.
VALIDITY DATE OF REGISTRATION28-11-2019 - 27-11-2024

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1WristOx2 Model 3150 with USB3150 USB
2WristOx2 Model 3150 with BLE3150 BLE
3Fingerclip Sensor Adult, for WristOx8000AA-WO2
4Reusable Flex Snsor for WristOx2, Adult8000J-WO2
5Soft Sensor Small for 3150 WristOx28000SS-WO2
6Soft Sensor Medium for 3150 WristOx28000SM-WO2
7Soft Sensor Large for 3150 WristOx28000SL-WO2
8Adapter Cable for WristOx23150I
9Model 8000AA FINGER CLIP SENSOR8000AA
10Model 8000AP PED FINGER CLIP SENSOR8000AP
11Model 8000Q2 EAR CLIP SNSR8000Q2
12MODEL 8000R REFLECTANCE SNSR8000R
13Forehead reflectance sensor holder for 8000R Sensor8000H
14MODEL 8000SS SOFT SENSOR SMALL 8000SS
15MODEL 8000SM SOFT SENSOR MEDIUM8000SM
16MODEL 8000SL SOFR SENSOR LARGE 8000SL
17Adult Reusable Flex SpO2 sensors with FlexiWrap8000J
18Flexiwrap, Adult8000JFW
196000CA SENSORS CLOTH ADULT 24CT6000CA
206000CP SENSOR CLOTH PED 24CT6000CP
216000CI SNSR CLOTH INFANT 24CT6000CI
22Model 7000A Flexi-Form III Disposable Sensor7000A
23Model 7000P Flexi-Form III Disposable Sensor7000P
24Model 7000I Flexi-Form III Disposable Sensor7000I
256500MA Standard Disposable Durafoam Sensor6500MA
266500SA Small Disposable Durafoam Sensor6500SA
27Carrying Case3100CC
28PC USB Interface Cable3150SC
29Adjustable Wrist Stap for WO23150WB
30Wrist Band Extender3100WBE
31nVISION Software for Microsoft WindowsnVISION