BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Insignis Syringe Infusion System

    Reg #: 3018229072 · FEI: 3018229072 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    INNOVATIVE HEALTH SCIENCES
    Registration Number
    3018229072
    FEI Number
    3018229072
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1108 Kings Hwy, Suite 4
    City
    Chester
    State
    NY
    ZIP
    10918
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232328

    Owner / Operator

    Firm Name
    Innovative Health Sciences
    Operator Number
    10076716
    Address
    1108 Kings Hwy, Suite 4
    City
    Chester
    State
    NY
    Postal Code
    10918
    Country
    US
    Correspondent
    Shepard G Bentley

    Products

    Device Name Product Code
    Immunoglobulin G (Igg) Infusion System PKP
    Pump, Infusion FRN
    Set, Administration, Intravascular FPA

    Proprietary Names

    Insignis Syringe Infusion System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198