This facility is provided to enable any interested parties to search for Registered Medical Device, Registered CAB, Licensed Establishments under Section 5, 10, 15 of Medical Device Act 2012 (Act 737) respectively and Notified Medical Device under Medical Device (Exemption) Order 2016. Any party who wishes to know whether an establishment who is dealing with medical device has been licensed under Act 737 may search the establishment by inserting the establishment name or license number in the searching field below.


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DEVICE DETAILS

NAME OF DEVICEANAESTHESIA FACE MASKS PACKS
ESTABLISHMENT NAMET T MEDICAL MANAGEMENT SDN BHD
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGB655471188318
BRAND NAMEFLEXICARE
MEDICAL DEVICE CATEGORYMD 0100 - GENERAL NON-ACTIVE, NON-IMPLANTABLE MEDICAL DEVICES
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONPRE-FILLED INFLATABLE ANAESTHETIC FACE MASK THE PRE-FILLED DISPOSABLE ANAESTHESIA FACE MASK IS AVAILABLE IN 6 SIZES FROM NEONATAL TO LARGE ADULT, WITH INDIVIDUALLY COLOUR CODED HOOKS FOR EASE OF IDENTIFICATION. COMPATIBLE WITH ALL STANDARD CATHETER MOUNTS AND BREATHING SYSTEMS WITH 22 MM & 15MM CONNECTORS. SCENTED INFLATABLE DISPOSABLE FACE MASK SOME PATIENTS RECEIVING ANAESTHESIA, PARTICULARLY CHILDREN, CAN FIND THE EXPERIENCE UNPLEASANT. THE FLEXICARE RANGE OF SCENTED ANAESTHESIA FACE MASKS ARE TO HELP OVERCOME THIS PROBLEM AND ARE AVAILABLE IN LEMON, STRAWBERRY AND VANILLA. SILICONE REUSABLE ANAESTHETIC FACE MASK THE REUSABLE SILICONE ANAESTHESIA FACE MASKS ARE FULLY AUTOCLAVABLE UP TO 50 TIMES. THE MOULDED TEXTURE OF THE RIM ENSURES MAXIMUM PATIENT COMFORT AND A TIGHT SEAL, WHILE THE TRANSPARENT FACE PIECES ALLOWS PATIENT MONITORING, AT ALL TIMES. 22MM AND 15 MM CONNECTORS ENSURE COMPATIBILITY WITH ALL STANDARD CATHETER MOUNTS AND BREATHING SYSTEMS. THE DEVICES ARE SUPPLIED NON-STERILE AND SINGLE-USE EXCLUDING SILICONE REUSABLE FACE MASK WHICH IS SUPPLIED NON-STERILE AND IS REUSABLE.
DEVICE INTENDED PURPOSEFLEXICARE´S ANAESTHESIA FACE MASK ARE GENERALLY USED FOR PRE-OXYGENATING THE PATIENT IN THE OPERATING THEATRE BEFORE THEY INTUBATE AND PUT THE PATIENT UNDER ANAESTHESIA. THE FACE MASK CAN ALSO BE USED FOR DELIVERING ANAESTHETIC GASSES IF THE PATIENT REFUSES INTRAVENOUS NEEDLES, ESPECIALLY WITH CHILDREN. THE FACEMASK CAN ALSO BE USED FOR BAG-MASK VENTILATION (BMV) IN A RESUSCITATION SETTING. FINALLY, IT CAN ALSO BE USED FOR NON-INVASIVE VENTILATION (NIV) IN PATIENTS WITH RESPIRATORY COMPROMISE. EACH ANAESTHESIA FACE MASK VARIANT CONSISTS OF A CONTOURED SHELL THAT SITUATES ON PATIENT FACE AND CAN BE SUPPLIED WITH OXYGEN TUBES, BREATHING SYSTEM AND CATHETER MOUNT IF REQUIRED. FLEXICARE SUPPLIES A RANGE OF ANAESTHESIA FACE MASK WITH DETACHABLE HOOK RING, WHICH ALLOW THE MASK TO BE HELD IN PLACE WITH A HEAD STRAP FOR DELIVERING NIV. FLEXICARE´S FACE MASKS ARE INTENDED TO BE USED FOR ANAESTHETIC GAS OR OXYGEN SUPPLY TO THE PATIENT BY TRAINED PERSONNEL, IN HOME, HEALTHCARE AND EMERGENCY ENVIRONMENTS.
VALIDITY DATE OF REGISTRATION02/11/2023 - 01/11/2028

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Anaesthesia Face Mask Pre-Filled Inflatable Single Use Extra Large Adult Size 6038-51-390
2Anaesthesia Face Mask Pre-Filled Inflatable Single Use Large Adult Size 5038-51-400
3Anaesthesia Face Mask Pre-Filled Inflatable Single Use Large Adult Size 5+Elbow+HMEF with Luer Port038-51-400/A
4Anaesthesia Face Mask Inflatable Single Use Lemon Scented Large Adult Size 5038-51-400SFL
5Anaesthesia Face Mask Inflatable Single Use Vanilla Scented Large Adult Size 5038-51-400SFP
6Anaesthesia Face Mask Silicone Reusable Large Adult Size 5038-51-400SIL
7Anaesthesia Face Mask Pre-Filled Inflatable Single Use Adult Size 4038-51-410
8Anaesthesia Face Mask Pre-Filled Inflatable Single Use Adult Size 4 + HMEF with Luer Port + Elbow038-51-410/A
9Anaesthesia Face Mask Inflatable Single Use Lemon Scented Adult Size 4038-51-410SFL
10Anaesthesia Face Mask Inflatable Single Use Vanilla Scented Adult Size 4038-51-410SFP
11Anaesthesia Face Mask Silicone Reusable Adult Size 4038-51-410SIL
12Anaesthesia Face Mask Pre-Filled Inflatable Single Use Large Child Size 3038-52-415
13Anaesthesia Face Mask Pre-Filled Inflatable Single Use Large Child Size 3 + Mini HMEF + Elbow038-52-415/A
14Anaesthesia Face Mask Inflatable Single Use Lemon Scented Large Child Size 3038-52-415SFL
15Anaesthesia Face Mask Inflatable Single Use Vanilla Scented Large Child Size 3038-52-415SFP
16Anaesthesia Face Mask Inflatable Single Use Strawberry Scented Large Child Size 3038-52-415SFS
17Anaesthesia Face Mask Silicone Reusable Large Child Size 3038-52-415SIL
18Anaesthesia Face Mask Pre-Filled Inflatable Single Use Medium Child Size 2038-52-420
19Anaesthesia Face Mask Pre-Filled Inflatable Single Use Medium Child Size 2 + Mini HMEF + Elbow038-52-420/A
20Anaesthesia Face Mask Inflatable Single Use Lemon Scented Medium Child Size 2038-52-420SFL
21Anaesthesia Face Mask Inflatable Single Use Vanilla Scented Medium Child Size 2038-52-420SFP
22Anaesthesia Face Mask Inflatable Single Use Strawberry Scented Medium Child Size 2038-52-420SFS
23Anaesthesia Face Mask Silicone Reusable Medium Child Size 2038-52-420SIL
24Anaesthesia Face Mask Pre-Filled Inflatable Single Use Small Child Size 1038-52-430
25Anaesthesia Face Mask Inflatable Single Use Lemon Scented Small Child Size 1038-52-430SFL
26Anaesthesia Face Mask Inflatable Single Use Vanilla Scented Small Child Size 1038-52-430SFP
27Anaesthesia Face Mask Inflatable Single Use Strawberry Scented Small Child Size 1038-52-430SFS
28Anaesthesia Face Mask Silicone Reusable Small Child Size 1038-52-430SIL
29Anaesthesia Face Mask Pre-Filled Inflatable Single Use Neonatal Size 0038-53-440
30Anaesthesia Face Mask Inflatable Single Use Lemon Scented Neonatal Size 0038-53-440SFL
31Anaesthesia Face Mask Inflatable Single Use Vanilla Scented Neonatal Size 0038-53-440SFP
32Anaesthesia Face Mask Inflatable Single Use Strawberry Scented Neonatal Size 0038-53-440SFS
33Anaesthesia Face Mask Silicone Reusable Neonatal Size 0038-53-440SIL
34Anaesthesia Face Mask Small Child Size 1 with Detachable Elbow + Mini HMEF + Catheter Mount038-61-351
35Anaesthesia Face Mask Pack with Detachable Elbow + Mini HMEF + Catheter Mount Medium Child Size 2038-61-352
36Anaesthesia Face Mask Pack with Detachable Elbow + Mini HMEF + Catheter Mount Size Large Child 3038-61-353
37Anaesthesia Face Mask Pack with Detachable Elbow + HMEF + Catheter Mount Adult Size 4038-61-354
38Anaesthesia Face Mask Pack with Detachable Elbow + HMEF + Catheter Mount Size Large Adult 5038-61-355
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