BEUDAMED
    FDA Registration Active 🇺🇸 United States

    HydraGuard 10" UltraFilter Flush

    Reg #: 3003337893 · FEI: 3003337893 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NEPHROS, INC.
    Registration Number
    3003337893
    FEI Number
    3003337893
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    380 Lackawana Place
    City
    South Orange
    State
    NJ
    ZIP
    07079
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161467

    Owner / Operator

    Firm Name
    Nephros, INC.
    Operator Number
    9053647
    Address
    380 Lackawanna Place
    City
    South Orange
    State
    NJ
    Postal Code
    07079
    Country
    US
    Correspondent
    Vashone R Thomas

    Products

    Device Name Product Code
    System, Water Purification, General Medical Use NHV

    Proprietary Names

    HydraGuard 10" UltraFilter Flush HydraGuard 10" UltraFilter HydraGuard 20" UltraFilter

    Establishment Types

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