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    FDA UDI In Commercial Distribution 🇺🇸 United States

    AP 223-01 MICROBORE ADMINISTRATION SET WITH VENTED/NON-VENTED SPIKE,

    DI: 17290109154869 · Model: 12003-000-0033 · EITAN MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    AP 223-01 MICROBORE ADMINISTRATION SET WITH VENTED/NON-VENTED SPIKE,
    Primary DI
    17290109154869
    Version / Model
    12003-000-0033
    Company Name
    EITAN MEDICAL LTD
    Labeler DUNS
    533108028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-14
    Public Version
    1
    Public Version Date
    2023-03-22
    Public Version Status
    New
    Public Device Record Key
    cd49fe91-bf5b-4f21-b035-75ee92d99792

    Device Description

    MICROBORE ADMINISTRATION SET WITH VENTED/NON-VENTED SPIKE, FX ADMINISTRATION CASSETTE, BACK CHECK VALVE, 0.2micron FILTER, SLIDE CLAMP, NEEDLELESS Y-SITE AND SPIN MALE LUER LOCK

    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
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    FPA Set, Administration, Intravascular

    GMDN Terms

    Code Name
    35833 Electric infusion pump administration set, single-use

    Identifiers

    Type ID
    Package 27290109154866
    Primary 17290109154869

    Premarket Submissions

    Submission Number Supplement Number
    K192860 000