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    FDA Registration Active 🇺🇸 United States

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    Reg #: 3014585508 · FEI: 3014585508 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Insulet Corporation
    Registration Number
    3014585508
    FEI Number
    3014585508
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 Nagog Park
    City
    Acton
    State
    MA
    ZIP
    01720
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231824

    Owner / Operator

    Firm Name
    INSULET CORPORATION
    Operator Number
    9056196
    Address
    100 Nagog Park, --
    City
    Acton
    State
    MA
    Postal Code
    01720
    Country
    US
    Correspondent
    Laetitia Cousin

    Products

    Device Name Product Code
    Calculator, Drug Dose NDC
    Continuous Glucose Monitor Informed Insulin Dose Calculator QRX

    Proprietary Names

    SmartBolus Calculator

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198