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DEVICE DETAILS

NAME OF DEVICENONIN ONYX VANTAGE FINGER PULSE OXIMETER
ESTABLISHMENT NAMEACUCARE SYSTEMS (M) SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC11120720-38475
BRAND NAMENONIN
MEDICAL DEVICE CATEGORYMD 1100 - GENERAL ACTIVE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONNoinin Medical's finfer pulse oximeters are small lightweight portable devices that display numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse by measuring the absorption of red and infrared (IR) light passing through perfused tissue. Changes in the absorption caused by the pulsation of blood in the vascular bed are used to determine oxygen saturation and pulse rate.
DEVICE INTENDED PURPOSEThe Nonin Finger Pulse Oximeter is a small, lightweight portable device intended for used in measuring and displaying functional hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused.
VALIDITY DATE OF REGISTRATION06/01/2020 - 05/01/2025

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Onyx II 9550 Pulse Oximeter9550
2Onyx Vantage 9590 Pulse Oximeter9590
3Onyx3 9591 Finger Pulse Oximeter9591
49500CC- Carrying Case, Black2003-102
59590 Lanyard6918-000
6Retractable Lanyard6919-002
7Fingertip Carrying Case5097-000
8Protective Carrying Case3802-000
9Fingertip Lanyard5096-000
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