BEUDAMED
    FDA Registration Active 🇺🇸 United States

    H2H Water Filter

    Reg #: 3003337893 · FEI: 3003337893 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    7
    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
    K112314

    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
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    H2H Water Filter H2H Infusion Set H2H Substitution Filter H2H Rinse Line OLpur H2H Hemodiafiltration Module OLpur MD220 Hemodiafiltration Filter Nephros On-Line Mid-Dilution Hemodiafiltration System

    Establishment Types

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