BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TANDEM DIABETES CARE, INC.

    Reg #: 3007981285 · FEI: 3007981285 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    25
    Establishment Types
    5
    Classifications
    14

    Registration Details

    Registration Name
    TANDEM DIABETES CARE, INC.
    Registration Number
    3007981285
    FEI Number
    3007981285
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    12400 High Bluff Drive
    City
    San Diego
    State
    CA
    ZIP
    92130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223213
    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
    Pump, Infusion, Insulin LZG
    Tape And Bandage, Adhesive KGX
    Sensor, Glucose, Invasive, Non-Adjunctive PQF
    Automated Insulin Dosing , Threshold Suspend OZO
    Continuous Glucose Monitor Secondary Display PJT
    Interoperable Automated Glycemic Controller QJI
    Interoperable Automated Glycemic Controller, Insulin Suspend QJS
    Calculator, Drug Dose NDC
    Insulin Pump Secondary Display PKU
    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor OYC
    Sensor, Glucose, Invasive MDS
    Continuous Glucose Monitor Retrospective Data Analysis Software PHV
    Accessories, Pump, Infusion MRZ

    Proprietary Names

    Tandem Mobi System Alternate Controller Enabled Insulin Infusion Pump t:slim X2 Tandem Mobi Adhesive Sleeve T:slim X2 Insulin Pump t:slim X2 with Basal-IQ t:slim X2 Insulin Pump t:slim X2 Insulin Pump with Basal-IQ t:flex Insulin Delivery System t:slim Insulin Delivery System t:slim insulin delivery system t:Connect mobile app Sugarmate Platform; Sugarmate, Alexa Skill Application; Sugarmate, Android Mobile Application; Sugarmate, iOS Mobile App t:slim X2 with Basal-IQ technology t:slim X2 with Basal-IQ Technology Control-IQ Technology t:Connect Mobile App t:slim X2 with Control-IQ technology t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM t:slim G4 System t:slim pump insulin delivery system Sugarmate Platform Tandem Source t:connect Web Application Tandem Device Updater

    Establishment Types

    Remanufacture Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device