BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    DUAL MASK-PAEDIATRIC MC MALE W/CO2 MONITORING W/FILTER (USA)

    DI: 05055788754749 · Model: 032-12-145U · FLEXICARE MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    DUAL MASK-PAEDIATRIC MC MALE W/CO2 MONITORING W/FILTER (USA)
    Primary DI
    05055788754749
    Version / Model
    032-12-145U
    Company Name
    FLEXICARE MEDICAL LIMITED
    Labeler DUNS
    504406273
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-10-04
    Public Version
    4
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    812153cb-8902-4db6-bf91-336616a55d02

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    Yes
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

    GMDN Terms

    Code Name
    35171 Rebreathing oxygen face mask

    Identifiers

    Type ID
    Primary 05055788754749

    Premarket Submissions

    Submission Number Supplement Number
    K133516 000