BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BETA BIONICS, INC.

    Reg #: 3019004087 · FEI: 3019004087 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    13
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    BETA BIONICS, INC.
    Registration Number
    3019004087
    FEI Number
    3019004087
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    11 Hughes
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223846

    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
    Alternate Controller Enabled Insulin Infusion Pump QFG
    Set, Administration, Intravascular FPA
    Syringe, Piston FMF
    Insulin Pump Secondary Display PKU
    Needle, Hypodermic, Single Lumen FMI
    Tubes, Vials, Systems, Serum Separators, Blood Collection JKA
    Interoperable Automated Glycemic Controller QJI

    Proprietary Names

    iLet Bionic Pancreas: iLet ACE Pump; iLet Charger; iLet Case, iLet Clip iLet Cartridge Kit iLet Connect Adapter iLet Insulin Infusion Kit - Contact Detach iLet Insulin Infusion Kit – Contact Detach (23", 6mm) iLet Insulin Infusion Kit – Inset (23", 6mm) iLet Insulin Infusion Kit – Inset (32", 6mm) Bionic Circle App, iOS Bionic Circle App, Android iLet Insulin Infusion Kit - Flex (23", 6mm) iLet Insulin Infusion Kit - Flex (32", 6mm) iLet Insulin Infusion Kit – Inset iLet Bionic Pancreas: iLet Dosing Decision Software

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Repack or Relabel Medical Device