BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Prometra Programmable Infusion Pump System

    Reg #: 3030198397 · FEI: 3030198397 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Infusyn Therapeutics
    Registration Number
    3030198397
    FEI Number
    3030198397
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    121 Shelley Drive, Suite 2H
    City
    Hackettstown
    State
    NJ
    ZIP
    07840
    Country
    US

    Regulatory Submissions

    PMA Number
    P080012

    Owner / Operator

    Firm Name
    Infusyn Therapeutics
    Operator Number
    10089601
    Address
    121 Shelley Drive, Suite 2H
    City
    Hackettstown
    State
    NJ
    Postal Code
    07840
    Country
    US
    Correspondent
    Whitney G Torning

    Products

    Device Name Product Code
    Pump, Infusion, Implanted, Programmable LKK

    Proprietary Names

    Prometra Programmable Infusion Pump System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility