BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Tablo® Hemodialysis System

    Reg #: 3038138522 · FEI: 3038138522 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Baja Fur S.A. de C.V.
    Registration Number
    3038138522
    FEI Number
    3038138522
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Blv. Agua Caliente 8582-5, Zona Centro
    City
    Tijuana BC. Baja California
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K190793

    Owner / Operator

    Firm Name
    Outset Medical, Inc.
    Operator Number
    10047467
    Address
    3052 Orchard Drive
    City
    San Jose
    State
    CA
    Postal Code
    95134
    Country
    US

    US Agent

    Business Name
    Outset Medical Inc
    Contact Name
    Dinamarie Stefani
    Address
    3052 Orchard Dr
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US
    Email
    [email protected]
    Phone
    669 2318200

    Products

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

    Proprietary Names

    Tablo® Hemodialysis System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility