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DEVICE DETAILS

NAME OF DEVICEMULTI-4 CO-OXIMETER CONTROLS
ESTABLISHMENT NAMESTRAITS SCIENTIFIC (M) SDN BHD
REGISTRATION NOIVDB8543919-35138
BRAND NAMEMULTI-4
DEVICE GROUPING TYPEIVD CLUSTER
DEVICE DESCRIPTIONMulti-4 CO-Oximeter Control is comprised of the following ampule configurations: Level 1: with high THb, low %O2Hb and high %COHb consistent with values observed with victims of smoke inhalation and other similar situations. Level 2: is consistent with values observed in the normal population. Level 3: with low THb consistent with anemic patients. The %O2Hb and %COHB reflect low clinical threshold levels.
DEVICE INTENDED PURPOSEMulti-4 CO-Oximeter™ Control is a quality control material available in three levels designed to simulate conditions of tissue oxygenation.
VALIDITY DATE OF REGISTRATION01/10/2019 - 30/09/2024

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Multi-4 CO-Oximeter Control L10003315250
2Multi-4 CO-Oximeter Control L20003314250
3Multi-4 CO-Oximeter Control L30003313250
4Multi-4 CO-Oximeter Control Multi Pack0003316200
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