BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Flexicare

    DI: 05055931103783 · Model: 038-31-602U · FLEXICARE MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Flexicare
    Primary DI
    05055931103783
    Version / Model
    038-31-602U
    Company Name
    FLEXICARE MEDICAL LIMITED
    Labeler DUNS
    504406273
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-08
    Public Version
    2
    Public Version Date
    2024-12-30
    Public Version Status
    Update
    Public Device Record Key
    35709b87-1d7c-4f1f-96e7-9efa41358815

    Device Description

    Adult BiPAP Single Limb H/W B/S 1.6m X 2 Filters

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    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
    BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
    BTT Humidifier, Respiratory Gas, (Direct Patient Interface)

    GMDN Terms

    Code Name
    37706 Ventilator breathing circuit, single-use

    Identifiers

    Type ID
    Primary 05055931103783