BEUDAMED
    FDA Registration Active 🇺🇸 United States

    JOBST BELLA LITE GAUNTLET

    Reg #: 1038963 · FEI: 1038963 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    BSN MEDICAL, INC.
    Registration Number
    1038963
    FEI Number
    1038963
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5825 CARNEGIE BLVD.
    City
    CHARLOTTE
    State
    NC
    ZIP
    28209
    Country
    US

    Regulatory Submissions

    510(k) Number
    K991570

    Owner / Operator

    Firm Name
    BSN medical GmbH
    Operator Number
    9047426
    Address
    Schutzenstrasse 1-3
    City
    Hamburg
    State
    DE-HH
    Postal Code
    22761
    Country
    DE

    Products

    Device Name Product Code
    Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) DWL

    Proprietary Names

    JOBST BELLA LITE GAUNTLET JOBST Armsleeves JOBST BELLA STRONG GAUNTLET JOBST BELLA LITE COMBINED JOBST BELLA STRONG ARMSLEEVE JOBST BELLA LITE ARMSLEEVE

    Establishment Types

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