BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    Sapphire Infusion Pump

    Reg #: 3010293992 · FEI: 3010293992 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    Eitan Medical LTD
    Registration Number
    3010293992
    FEI Number
    3010293992
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    29 Yad Haruzim St.
    City
    Netanya Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K141389

    Owner / Operator

    Firm Name
    Eitan Medical LTD
    Operator Number
    10045422
    Address
    29 Yad Haruzim St., Building 10
    City
    Netanya
    State
    IL-NOTA
    Postal Code
    4250529
    Country
    IL
    Correspondent
    Tally Eitan

    US Agent

    Business Name
    Z & B Enterprises, Inc.
    Contact Name
    Rhona Shanker
    Address
    12154 Darnestown Road, #236
    City
    Gaithersburg
    State
    MD
    ZIP
    20878
    Country
    US
    Email
    [email protected]
    Phone
    301 2519570

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Pump, Infusion FRN

    Proprietary Names

    Sapphire Infusion Pump

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device