BEUDAMED
    FDA Registration Active 🇺🇸 United States

    US INFUSION LLC. D/B/A TRUECARE BIOMEDIX-USA

    Reg #: 3008782867 · FEI: 3008782867 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    US INFUSION LLC. D/B/A TRUECARE BIOMEDIX-USA
    Registration Number
    3008782867
    FEI Number
    3008782867
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6356 Manor Ln Ste 101
    City
    South Miami
    State
    FL
    ZIP
    33143
    Country
    US

    Regulatory Submissions

    510(k) Number
    K121554

    Owner / Operator

    Firm Name
    US Infusion LLC. d/b/a Truecare Biomedix-USA
    Operator Number
    10028886
    Address
    6356 Manor Lane, Suite 101
    City
    South Miami
    State
    FL
    Postal Code
    33143
    Country
    US
    Correspondent
    Tracie L Davis

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Syringe, Piston FMF

    Establishment Types

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