BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TANDEM DIABETES CARE, INC.

    Reg #: 3016540876 · FEI: 3016540876 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    12
    Establishment Types
    4
    Classifications
    8

    Registration Details

    Registration Name
    TANDEM DIABETES CARE, INC.
    Registration Number
    3016540876
    FEI Number
    3016540876
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6495 Marindustry Place
    City
    San Diego
    State
    CA
    ZIP
    92121
    Country
    US

    Regulatory Submissions

    510(k) Number
    K203234
    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
    Alternate Controller Enabled Insulin Infusion Pump QFG
    Interoperable Automated Glycemic Controller QJI
    Pump, Infusion, Insulin LZG
    Interoperable Automated Glycemic Controller, Insulin Suspend QJS
    Calculator, Drug Dose NDC
    Tape And Bandage, Adhesive KGX
    Sensor, Glucose, Invasive, Non-Adjunctive PQF
    Automated Insulin Dosing , Threshold Suspend OZO

    Proprietary Names

    t:slim X2 with Control-IQ technology t:slim X2 t:slim pump insulin delivery system Tandem Mobi System t:slim X2 with Basal-IQ technology T:slim X2 Insulin Pump Control-IQ Technology t:slim X2 with Basal-IQ Technology Tandem Mobi Adhesive Sleeve t:slim X2 with Basal-IQ t:slim X2 Insulin Pump t:slim X2 Insulin Pump with Basal-IQ

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Remanufacture Medical Device Manufacture Device in the United States for Export Only