BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Toujeo Max Only

    Reg #: 3016525500 · FEI: 3016525500 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    31
    Establishment Types
    4
    Classifications
    2

    Registration Details

    Registration Name
    BIGFOOT BIOMEDICAL, INC.
    Registration Number
    3016525500
    FEI Number
    3016525500
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1820 McCarthy Boulevard, 1820 McCarthy Blvd
    City
    Milpitas
    State
    CA
    ZIP
    95035
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202145

    Owner / Operator

    Firm Name
    Bigfoot Biomedical, Inc.
    Operator Number
    10080568
    Address
    1820 McCarthy Boulevard, 1820 McCarthy Blvd
    City
    Milpitas
    State
    CA
    Postal Code
    95035
    Country
    US
    Correspondent
    Rodney Huang

    Products

    Device Name Product Code
    Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems QLG
    Injection Data Capture Device QOG

    Proprietary Names

    Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Lantus-Glargine Only Bigfoot Unity Diabetes Management System - Cap for Apidra/Admelog Only Bigfoot Unity Diabetes Management System - Cap for Basaglar Only Bigfoot Unity Diabetes Management System- For Fiasp and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Toujeo Only Bigfoot Unity-Mobile App Bigfoot Unity Diabetes Management System - Cap for Lantus-Glargine Only Bigfoot Unity Diabetes Management System - Cap for Toujeo Only Bigfoot Unity Diabetes Management System - Cap for Humalog-Lispro-Lyumjev Only Bigfoot Unity Diabetes Management System- For Fiasp and Basaglar Only Bigfoot Unity Diabetes Management System- For Fiasp and Lantus-Glargine Only Bigfoot Unity Diabetes Management System - Cap for Novolog-Aspart Only Bigfoot Unity Program Kit Bigfoot Unity Diabetes Management System - Cap for Fiasp Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Lantus-Glargine Only Bigfoot Unity Diabetes Management System- For Fiasp and Toujeo Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Basaglar Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Basaglar Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Toujeo Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Lantus -Glargine Only Bigfoot Unity Diabetes Management System- For Fiasp and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System - Cap for Levemir FlextTouch/Tresiba-Degludec Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Basaglar Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Toujeo Only Bigfoot Unity Diabetes Management System - Cap for Toujeo Max Only

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198