BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NxStage Cartridge Express

    Reg #: 3003464075 · FEI: 3003464075 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NXSTAGE MEDICAL, INC.
    Registration Number
    3003464075
    FEI Number
    3003464075
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    350 Merrimack St
    City
    LAWRENCE
    State
    MA
    ZIP
    01843
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133547

    Owner / Operator

    Firm Name
    Fresenius Medical Care Holdings, Inc.
    Operator Number
    10061218
    Address
    920 Winter Street
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US
    Correspondent
    Rachel Lloyd

    Products

    Device Name Product Code
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    NxStage Cartridge Express

    Establishment Types

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