BEUDAMED
    FDA Registration Inactive 🇺🇸 United States

    Byonyks Automated PD Set DS-1

    · Expires 2025
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    BYONYKS MEDICAL DEVICES INC
    Status
    Inactive
    Expiry Year
    2025
    Initial Importer
    No
    Address
    550 E Devon Ave Ste 140
    City
    Itasca
    State
    IL
    ZIP
    60143
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243371

    Owner / Operator

    Firm Name
    Byonyks Medical Devices Inc
    Operator Number
    10093651
    Address
    550 E Devon Ave, Suite 140
    City
    Itasca
    State
    IL
    Postal Code
    60143
    Country
    US
    Correspondent
    Eric J Flachbart

    Products

    Device Name Product Code
    Set, Administration, For Peritoneal Dialysis, Disposable KDJ
    System, Peritoneal, Automatic Delivery FKX

    Proprietary Names

    Byonyks Automated PD Set DS-1 Byonyks X-1 APD Cycler

    Establishment Types

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