BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iLet Insulin Infusion Kit – Inset (32", 6mm)

    Reg #: 3019004087 · FEI: 3019004087 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BETA BIONICS, INC.
    Registration Number
    3019004087
    FEI Number
    3019004087
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11 Hughes
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110771

    Owner / Operator

    Firm Name
    Beta Bionics, Inc.
    Operator Number
    10088071
    Address
    11 Hughes
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Neal Grant

    Products

    Device Name Product Code
    Syringe, Piston FMF

    Proprietary Names

    iLet Insulin Infusion Kit – Inset (32", 6mm) iLet Cartridge Kit iLet Insulin Infusion Kit – Inset (23", 6mm) iLet Insulin Infusion Kit – Contact Detach (23", 6mm)

    Establishment Types

    Repack or Relabel Medical Device