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DEVICE DETAILS

NAME OF DEVICEWIZARD FULL FACE MASK WITH HEADGEAR
ESTABLISHMENT NAMEERIKG SDN BHD
REGISTRATION NOGB10841721-76780
BRAND NAMEWIZARD
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONFull face mask
DEVICE INTENDED PURPOSEThe Mask is intended to provide an interface for Continuous Positive Airway Pressure (CPAP) or bi-level therapy. These masks are intended for single-patient reuse in the home and multi-patient, multi-use in the hospital environment. These masks are to be used on patients greater than 30 kg for whom positive airway pressure (CPAP or bi-level system) has been prescribed.
VALIDITY DATE OF REGISTRATION24/09/2021 - 23/09/2026

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1WiZARD 320 Full Face Mask with HeadgearSM08003
2WiZARD 320 Full Face Mask with HeadgearSM08002
3WiZARD 320 Full Face Mask with HeadgearSM08001
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