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    FDA UDI In Commercial Distribution 🇺🇸 United States

    AP209-01

    DI: 17290109155217 · Model: 12003-000-1027 · EITAN MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    AP209-01
    Primary DI
    17290109155217
    Version / Model
    12003-000-1027
    Company Name
    EITAN MEDICAL LTD
    Labeler DUNS
    533108028
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-03-05
    Public Version
    1
    Public Version Date
    2025-03-13
    Public Version Status
    New
    Public Device Record Key
    eb06bf3a-abf1-46c0-8788-d2c2f9cd528f

    Device Description

    Spiral set

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    FPA Set, Administration, Intravascular

    GMDN Terms

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

    Identifiers

    Type ID
    Package 27290109155214
    Primary 17290109155217

    Premarket Submissions

    Submission Number Supplement Number
    K192860 000