BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    AVEA

    DI: 10846446063660 · Model: 16341-04 · Carefusion Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AVEA
    Primary DI
    10846446063660
    Version / Model
    16341-04
    Company Name
    Carefusion Corporation
    Labeler DUNS
    830432451
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-03-31
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    48fc23fc-e3a6-4b1f-8276-082481c8d31c

    Device Description

    Kit, Heliox male DISS fittings

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    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
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CBK Ventilator, Continuous, Facility Use

    GMDN Terms

    Code Name
    43295 Helium/oxygen quick-connect coupling, male

    Identifiers

    Type ID
    Primary 10846446063660

    Customer Contacts

    Phone
    800-231-2466
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K103211 000