BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Erika of Texas

    Reg #: 3023981687 · FEI: 3008730267 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Erika of Texas
    Registration Number
    3023981687
    FEI Number
    3008730267
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    900 W Zaragosa Dr., Suite D
    City
    Pharr
    State
    TX
    ZIP
    78577
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141997

    Owner / Operator

    Firm Name
    Fresenius Medical Care Renal Therapies Group, LLC
    Operator Number
    9030510
    Address
    920 WINTER STREET, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US
    Correspondent
    Rachel Lloyd

    Products

    Device Name Product Code
    Accessories, Blood Circuit, Hemodialysis KOC

    Proprietary Names

    CritLine IV System

    Establishment Types

    Manufacture Medical Device