BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GASTROKLENZ INC. DBA CLOUDCATH

    Reg #: 3015882716 · FEI: 3015882716 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    GASTROKLENZ INC. DBA CLOUDCATH
    Registration Number
    3015882716
    FEI Number
    3015882716
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    665 3rd Street, Suite 250
    City
    San Francisco
    State
    CA
    ZIP
    94107
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212658

    Owner / Operator

    Firm Name
    GastroKlenz Inc. dba CloudCath
    Operator Number
    10085457
    Address
    665 3rd Street, Suite 250
    City
    San Francisco
    State
    CA
    Postal Code
    94107
    Country
    US

    Products

    Device Name Product Code
    System, Peritoneal, Automatic Delivery FKX

    Proprietary Names

    CloudCath Drain Set - Fresenius Configuration CloudCath Sensor (Sensing Hardware) CloudCath Connect - Patient Monitoring Software CloudCath CloudCath Drain Set - Baxter Configuration

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198