BEUDAMED
    FDA Registration Active 🇺🇸 United States

    t:slim G4 System

    Reg #: 3007981285 · FEI: 3007981285 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    3

    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

    PMA Number
    P140015

    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
    Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor OYC
    Sensor, Glucose, Invasive MDS
    Sensor, Glucose, Invasive, Non-Adjunctive PQF

    Proprietary Names

    t:slim G4 System t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM

    Establishment Types

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