BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MedSource Needleless PRN 6", Pinch Clamp, Rotary Male Luer Lock

    Reg #: 3003674698 · FEI: 3003674698 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    17
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    MedSource Labs, LLC
    Registration Number
    3003674698
    FEI Number
    3003674698
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8600 Shelby Court, Suite 100
    City
    Chanhassen
    State
    MN
    ZIP
    55317
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140402

    Owner / Operator

    Firm Name
    MEDSOURCE LABS, LLC
    Operator Number
    9050135
    Address
    8600 Shelby Court, Suite 100, --
    City
    Chanhassen
    State
    MN
    Postal Code
    55317
    Country
    US
    Correspondent
    Emilie Andrews

    Products

    Device Name Product Code
    Set, I.V. Fluid Transfer LHI

    Proprietary Names

    MedSource Needleless PRN 6", Pinch Clamp, Rotary Male Luer Lock MedSource 72", 60 Drop, Y-Site, Needle PRN MedSource 83", 60 Drop, Split Septum Y-Site, Needle PRN, 6" ext. set MedSource 83", 10 Drop, Split Septum Y-Site, Needle PRN MedSource 83", 15 Drop, Split Septum Y-Site, Needle PRN MedSource 83", 15 Drop, Split Septum Y-Site, Needle PRN, 6" ext. set MedSource Flow Regulator, 19", Split Septum Y-Site, Side Clamp MedSource 88", 60 Drop, Split Septum Y-Site, Needleless PRN MedSource 96", 10 Drop, two (2) Split Septum Y-Sites, Flow Regulator MedSource 83", 60 Drop, Split Septum Y-Site, Needle PRN MedSource Needleless PRN, 10", Pinch Clamp, Rotary Male Luer Lock MedSource 72", 15 Drop, Y-Site, Needle PRN MedSource Needleless PRN, 8", Pinch Clamp, Rotary Male Luer Lock MedSource 72", 10 Drop, Y-Site, Needle PRN MedSource Male Luer Lock, 21" MedSource 83", 10 Drop, Split Septum Y-Site, Needle PRN, 6" ext. set MedSource Needleless PRN, 6", Split Septum Y-Site, Side Clamp

    Establishment Types

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