BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Moda-flx Hemodialysis System

    Reg #: 3015349756 · FEI: 3015349756 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    3

    Registration Details

    Registration Name
    DIALITY, INC.
    Registration Number
    3015349756
    FEI Number
    3015349756
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    181 Technology Dr Ste 150
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K233798

    Owner / Operator

    Firm Name
    Diality, Inc.
    Operator Number
    10091317
    Address
    181 Technology Dr., Suite 150
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Khalid Mansoor

    Products

    Device Name Product Code
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Subsystem, Water Purification FIP

    Proprietary Names

    Moda-flx Hemodialysis System

    Establishment Types

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