BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Adult Dual Heated Wire Breathing Circuit 1.6M (63") (Kit 1)

    DI: 05055788708674 · Model: 038-31-201U · FLEXICARE MEDICAL LIMITED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Adult Dual Heated Wire Breathing Circuit 1.6M (63") (Kit 1)
    Primary DI
    05055788708674
    Version / Model
    038-31-201U
    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
    5
    Public Version Date
    2022-10-24
    Public Version Status
    Update
    Public Device Record Key
    cb5108a4-5d63-4cc7-9b0e-0fed6c41aa6d

    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
    Yes
    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 05055788708674

    Premarket Submissions

    Submission Number Supplement Number
    K150900 000