BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEPHROS, INC.

    Reg #: 3003337893 · FEI: 3003337893 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    23
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    NEPHROS, INC.
    Registration Number
    3003337893
    FEI Number
    3003337893
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    380 Lackawana Place
    City
    South Orange
    State
    NJ
    ZIP
    07079
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161304

    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
    Subsystem, Water Purification FIP
    System, Water Purification, General Medical Use NHV
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI

    Proprietary Names

    EndoPur Endotoxin 30” Filter EndoPur Endotoxin 10” Filter EndoPur Endotoxin 20” Filter SSU-H UltraFilter DSU-H UltraFilter SSUmini UltraFilter SSU-D UltraFilter SSUmini JG UltraFilter DSU-D UltraFilter S100 In-Line S100 Shower Handheld S100 Sink Spray S100 Sink Spout HydraGuard 10" UltraFilter Flush HydraGuard 10" UltraFilter HydraGuard 20" UltraFilter Nephros On-Line Mid-Dilution Hemodiafiltration System OLpur MD220 Hemodiafiltration Filter H2H Substitution Filter H2H Infusion Set H2H Water Filter H2H Rinse Line OLpur H2H Hemodiafiltration Module

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device for Another Party (Contract Manufacturer)