BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GS-3045-H 4-Chamber Leg Sleeve - Half

    Reg #: 2424387 · FEI: 2424387 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    35
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIO COMPRESSION SYSTEMS, INC.
    Registration Number
    2424387
    FEI Number
    2424387
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    120 WEST COMMERCIAL AVE.
    City
    MOONACHIE
    State
    NJ
    ZIP
    07074
    Country
    US

    Regulatory Submissions

    510(k) Number
    K171793

    Owner / Operator

    Firm Name
    Bio Compression Systems, Inc
    Operator Number
    2424387
    Address
    120 West Commercial Ave, --
    City
    Moonachie
    State
    NJ
    Postal Code
    07074
    Country
    US
    Correspondent
    Marc L Somelofski

    Products

    Device Name Product Code
    Sleeve, Limb, Compressible JOW

    Proprietary Names

    GS-3045-H 4-Chamber Leg Sleeve - Half GWA-3045-M 4-Chamber Leg Sleeve - Wide Adjustable Medium GW-3045-L 4-Chamber Leg Sleeve - Large GS-3035-SH-L-R 4-Chamber Arm & Shoulder Sleeve - Large Right GXW-3045 4-Chamber Leg Sleeve - Extra Wide GS-3035-SH/L 4-Chamber Arm & Shoulder Sleeve - Large GA-3045-L 4-Chamber Adjustable Leg Sleeve - Large GWA-3045-H 4-Chamber Leg Sleeve - Wide Adjustable Half GS-3035-SH-M-L 4-Chamber Arm & Shoulder Sleeve - Medium Left GW-3045-M 4-Chamber Leg Sleeve - Medium GS-3035-SH-L-L 4-Chamber Arm & Shoulder Sleeve - Large Left GV-3000 4-Chamber Vest GW-3045-S 4-Chamber Leg Sleeve - Small GS-3035-SH/S 4-Chamber Arm & Shoulder Sleeve - Small GN-3045-M 4-Chamber Leg Sleeve - Medium Narrow GA-3045-S 4-Chamber Adjustable Leg Sleeve - Small GS-3035-S 4-Chamber Arm Sleeve - Small GS-3045-L 4-Chamber Leg Sleeve - Large GS-3045-S 4-Chamber Leg Sleeve - Small GA-3045-M 4-Chamber Adjustable Leg Sleeve - Medium GN-3045-S 4-Chamber Leg Sleeve - Small Narrow GXWA-3045 4-Chamber Leg Sleeve - Extra Wide Adjustable GA-3045-H 4-Chamber Adjustable Leg Sleeve - Half GW-3045-H 4-Chamber Leg Sleeve - Half Wide GWA-3045-L 4-Chamber Leg Sleeve - Wide Adjustable Large GN-3045-L 4-Chamber Leg Sleeve - Large Narrow SC-2004FC-OC Sequential Circulator GS-3035-L 4-Chamber Arm Sleeve - Large GS-3035-M 4-Chamber Arm Sleeve - Medium GS-3035-SH-S-R 4-Chamber Arm & Shoulder Sleeve - Small Right GS-3035-SH/M 4-Chamber Arm & Shoulder Sleeve - Medium GS-3045-M 4-Chamber Leg Sleeve - Medium GS-3035-SH-S-L 4-Chamber Arm & Shoulder Sleeve - Small Left GWA-3045-S 4-Chamber Leg Sleeve - Wide Adjustable Small GS-3035-SH-M-R 4-Chamber Arm & Shoulder Sleeve - Medium Right

    Establishment Types

    Manufacture Medical Device