BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Patient Circuit

    DI: 17290013641981 · Model: V64-0033 · FLIGHT MEDICAL INNOVATIONS LTD
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Patient Circuit
    Primary DI
    17290013641981
    Version / Model
    V64-0033
    Company Name
    FLIGHT MEDICAL INNOVATIONS LTD
    Labeler DUNS
    600023576
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-29
    Public Version
    5
    Public Version Date
    2022-10-24
    Public Version Status
    Update
    Public Device Record Key
    6326bf97-e138-4375-913d-9054ef843337

    Device Description

    F60 SL Autoclav Flow Sensor Kit

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    NOU Continuous, Ventilator, Home Use
    CBK Ventilator, Continuous, Facility Use

    GMDN Terms

    Code Name
    37706 Ventilator breathing circuit, single-use

    Identifiers

    Type ID
    Primary 17290013641981

    Premarket Submissions

    Submission Number Supplement Number
    K120726 000