BEUDAMED
    FDA Registration Active 🇺🇸 United States

    10% Polyvinylpyrrolidone (PVP) Solution with Human Serum Albumin (HSA)

    Reg #: 3036495174 · FEI: 3036495174 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    IRVINE SCIENTIFIC LLC
    Registration Number
    3036495174
    FEI Number
    3036495174
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1830 E Warner Ave
    City
    Santa Ana
    State
    CA
    ZIP
    92705
    Country
    US

    Regulatory Submissions

    510(k) Number
    K991343

    Owner / Operator

    Firm Name
    IRVINE SCIENTIFIC LLC
    Operator Number
    10092955
    Address
    1830 E Warner Ave
    City
    Santa Ana
    State
    CA
    Postal Code
    92705
    Country
    US
    Correspondent
    Ashley M Werner

    Products

    Device Name Product Code
    Media, Reproductive MQL

    Proprietary Names

    10% Polyvinylpyrrolidone (PVP) Solution with Human Serum Albumin (HSA) 7% Polyvinylpyrrolidone (PVP) Solution with Human Serum Albumin (HSA)

    Establishment Types

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