BEUDAMED
    FDA Registration Active 🇺🇸 United States

    t:slim X2 with Basal-IQ

    Reg #: 3013756811 · FEI: 3013756811 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Tandem Diabetes Care, INC.
    Registration Number
    3013756811
    FEI Number
    3013756811
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10151 Barnes Canyon Road, 10151 Barnes Canyon Road
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    PMA Number
    P180008

    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
    Sensor, Glucose, Invasive, Non-Adjunctive PQF
    Automated Insulin Dosing , Threshold Suspend OZO

    Proprietary Names

    t:slim X2 with Basal-IQ t:slim X2 Insulin Pump t:slim X2 t:slim X2 Insulin Pump with Basal-IQ

    Establishment Types

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