BEUDAMED
    FDA Registration Active 🇺🇸 United States

    T:slim X2 Insulin Pump

    Reg #: 3007981285 · FEI: 3007981285 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    1

    Registration Details

    Registration Name
    TANDEM DIABETES CARE, INC.
    Registration Number
    3007981285
    FEI Number
    3007981285
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    12400 High Bluff Drive
    City
    San Diego
    State
    CA
    ZIP
    92130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232380

    Owner / Operator

    Firm Name
    Tandem Diabetes Care, Inc.
    Operator Number
    10039506
    Address
    12400 High Bluff Drive
    City
    San Diego
    State
    CA
    Postal Code
    92130
    Country
    US
    Correspondent
    Mark Tarby

    Products

    Device Name Product Code
    Alternate Controller Enabled Insulin Infusion Pump QFG

    Proprietary Names

    T:slim X2 Insulin Pump

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Remanufacture Medical Device Manufacture Medical Device