BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SCIg60 Infusion System

    Reg #: 3007428065 · FEI: 3007428065 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DIMCOGRAY CORP. DBA DG MEDICAL
    Registration Number
    3007428065
    FEI Number
    3007428065
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    900 Dimco Way
    City
    Centerville
    State
    OH
    ZIP
    45458
    Country
    US

    Regulatory Submissions

    510(k) Number
    K142319

    Owner / Operator

    Firm Name
    DimcoGray Corp. DBA DG Medical
    Operator Number
    10038945
    Address
    900 Dimco Way
    City
    Centerville
    State
    OH
    Postal Code
    45458
    Country
    US
    Correspondent
    Astrid Mikrut

    Products

    Device Name Product Code
    Immunoglobulin G (Igg) Infusion System PKP

    Proprietary Names

    SCIg60 Infusion System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)