BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fresenius USA Manufacturing, Inc.

    Reg #: 3005162618 · FEI: 1527681 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    7
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    Fresenius USA Manufacturing, Inc.
    Registration Number
    3005162618
    FEI Number
    1527681
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    750 North Lallendorf Rd
    City
    OREGON
    State
    OH
    ZIP
    43616
    Country
    US

    Regulatory Submissions

    510(k) Number
    K191474

    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
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Subsystem, Water Purification FIP
    Accessories, Blood Circuit, Hemodialysis KOC
    Disinfectant, Dialysate Delivery System NII
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    NaturaLyte Dry Bicarbonate Concentrate NaturaLyte Dry Bicarbonate (08-4112-2) NaturaLyte Liquid Acid Concentrate Citrasate Liquid Acid Concentrate 5008X CAREsystem Granuflo Dry Acid Concentrate Citrasate Dry Acid Concentrate

    Establishment Types

    Manufacture Medical Device