BEUDAMED
    FDA Registration Active 🇺🇸 United States

    iSage Rx™ (iSage Rx Basal Insulin Titration)

    Reg #: 3013498633 · FEI: 3013498633 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Amalgam Rx, Inc
    Registration Number
    3013498633
    FEI Number
    3013498633
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1007 N Orange St Ste 400
    City
    Wilmington
    State
    DE
    ZIP
    19801
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161865

    Owner / Operator

    Firm Name
    Amalgam Rx, Inc
    Operator Number
    10054581
    Address
    206 Alapocas Drive
    City
    Wilmington
    State
    DE
    Postal Code
    19803
    Country
    US
    Correspondent
    Ryan Sysko

    Products

    Device Name Product Code
    Calculator, Drug Dose NDC

    Proprietary Names

    iSage Rx™ (iSage Rx Basal Insulin Titration) Dose Check

    Establishment Types

    Manufacture Medical Device