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DEVICE DETAILS

NAME OF DEVICELARYNGEAL MASK AIRWAY
ESTABLISHMENT NAMEAARGYP SCIENTIFIC SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB8803822-83690
BRAND NAMEFUSHAN MEDICAL / ALMA (DUAL LUMEN)
MEDICAL DEVICE CATEGORYMD 0101 - Non-active devices for anaesthesia, emergency and intensive care
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONThe Laryngeal Mask Airway (LM) made from the raw material of medical grade silicone or PVC, have such good performance as the tube with appropriate hardness, excellent biocompatibility: non-irritant to delicate mucous membranes, smooth round shaft can be inimize trauma during insertion or withdrawal. The airway tube is highly flexible yet have a suitable degree of hardness, and the surface is finely embossed to enable smooth insertion, decreasing foreign body sensation and more comfortable to patients.
DEVICE INTENDED PURPOSEThe Laryngeal Mask Airway is applied to assist patients to breathe in the condition of anesthesia; artificial ventilation and patients non self-breath by establish a short-term and unfixed airway.
VALIDITY DATE OF REGISTRATION14/01/2022 - 13/01/2027

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Laryngeal Mask AirwayALMA 1.0
2Laryngeal Mask AirwayALMA 1.5
3Laryngeal Mask AirwayALMA 2.0
4Laryngeal Mask AirwayALMA 2.5
5Laryngeal Mask AirwayALMA 3.0
6Laryngeal Mask AirwayALMA 4.0
7Laryngeal Mask AirwayALMA 5.0
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