BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Outset Medical, Inc.

    Reg #: 3010355846 · FEI: 3010355846 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    Outset Medical, Inc.
    Registration Number
    3010355846
    FEI Number
    3010355846
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3052 Orchard Drive
    City
    San Jose
    State
    CA
    ZIP
    95134
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223248

    Owner / Operator

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

    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 Tablo Hemodialysis System Tablo Cartridge Tablo® Cartridge Tablo® Hemodialysis System; TabloCart™ with Prefiltration Drawer

    Establishment Types

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