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DEVICE DETAILS

NAME OF DEVICEOuFinity Medical Face Mask
ESTABLISHMENT NAMEGPI TECHNOLOGY SDN BHD
REGISTRATION NOGA6503121-71026
BRAND NAMEOuFinity
DEVICE GROUPING TYPESINGLE
DEVICE DESCRIPTIONA flexible, loose-fitting medical face mask designed to be placed over the mouth and/or nose of a user to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood,body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator).
DEVICE INTENDED PURPOSEThese masks could be used by the general public, patients and other persons to reduce the risk of spread of infections particularly in epidemic or pandemic situations by cover user's nose and mouth that provides a physical barrier from transmission of viruses, microorganisms, and body fluids.
VALIDITY DATE OF REGISTRATION10/09/2021 - 09/09/2026

LIST OF DEVICE

NONAME OF DEVICEDEVICE IDENTIFIER
1OuFinity Medical Face Mask9551012960000
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