BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tempo Smart Button

    Reg #: 1819470 · FEI: 1819470 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Eli Lilly and Company, Pharmaceutical Delivery Systems
    Registration Number
    1819470
    FEI Number
    1819470
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Lilly Corporate Center
    City
    Indianapolis
    State
    IN
    ZIP
    46285
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212217

    Owner / Operator

    Firm Name
    ELI LILLY AND CO.
    Operator Number
    1819470
    Address
    LILLY CORPORATE CENTER, Drop Code 1084
    City
    Indianapolis
    State
    IN
    Postal Code
    46285
    Country
    US
    Correspondent
    Karthik Iyer

    Products

    Device Name Product Code
    Injection Data Capture Device QOG
    Insulin Autoantibody Kit OCN

    Proprietary Names

    Tempo Smart Button

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device