BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GV-3000 4-Chamber Vest

    Reg #: 2424387 · FEI: 2424387 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    86
    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
    K142640

    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

    GV-3000 4-Chamber Vest G8-3035-SH-M-R 8-Chamber Arm & Shoulder Sleeve - Medium Right G8-3035-L 8-Chamber Arm Sleeve - Large A8-3045-L 8-Chamber Leg Sleeve - Large Adjustable GN8-3045-L 8-Chamber Leg Sleeve - Large Narrow SC-3008-DL Sequential Circulator GBA-3045-M-R Bio Abdominal - Medium Right leg A8-3045-S 8-Chamber Leg Sleeve - Small Adjustable GWA-3045-H 4-Chamber Leg Sleeve - Wide Adjustable Half GXW8-3045 8-Chamber Leg Sleeve - Extra Wide GV-3010-L-R Elite 8 Bio Vest - Large Right A8-3045-M 8-Chamber Leg Sleeve - Medium Adjustable GW-3045-S 4-Chamber Leg Sleeve - Small GWA8-3045-M 8-Chamber Leg Sleeve - Wide Adjustable Medium GBA-3045-L-L Bio Abdominal - Large Left leg GBA-3045-S-R Bio Abdominal - Small Right leg GV-3010-L-2 Elite 8 Vest with Bilateral Arms - Large GV-3010-M-2 Elite 8 Vest with Bilateral Arms - Medium GS-3035-SH/M 4-Chamber Arm & Shoulder Sleeve - Medium GWA8-3045-L 8-Chamber Leg Sleeve - Wide Adjustable Large GS-3035-SH-L-L 4-Chamber Arm & Shoulder Sleeve - Large Left SC-3008-DL-230 Sequential Circulator GV-3010-S-2 Elite 8 Vest with Bilateral Arms - Small GV-3010-L-L Elite 8 Bio Vest - Large Left GS-3035-SH/S 4-Chamber Arm & Shoulder Sleeve - Small GS-3035-M 4-Chamber Arm Sleeve - Medium GS-3035-SH-S-L 4-Chamber Arm & Shoulder Sleeve - Small Left GV-3010-S-L Elite 8 Bio Vest - Small Left GW8-3045-L 8-Chamber Leg Sleeve - Large Wide GW-3045-H 4-Chamber Leg Sleeve - Half Wide GA-3045-L 4-Chamber Adjustable Leg Sleeve - Large GS-3035-L 4-Chamber Arm Sleeve - Large GA-3045-M 4-Chamber Adjustable Leg Sleeve - Medium GBA-3045-L-R Bio Abdominal - Large Right leg GS-3035-SH-S-R 4-Chamber Arm & Shoulder Sleeve - Small Right G8-3035-SH-L-R 8-Chamber Arm & Shoulder Sleeve - Large Right GV-3010-M-L Elite 8 Bio Vest - Medium Left GS-3035-SH/L 4-Chamber Arm & Shoulder Sleeve - Large G8-3045-S 8-Chamber Leg Sleeve - Small GBA-3045-S-2 Bio Pants - Small GN-3045-S 4-Chamber Leg Sleeve - Small Narrow GXW-3045 4-Chamber Leg Sleeve - Extra Wide GA-3045-H 4-Chamber Adjustable Leg Sleeve - Half GW-3045-M 4-Chamber Leg Sleeve - Medium G8-3035-S 8-Chamber Arm Sleeve - Small GS-3035-SH-M-R 4-Chamber Arm & Shoulder Sleeve - Medium Right GS-3035-SH-M-L 4-Chamber Arm & Shoulder Sleeve - Medium Left GXWA8-3045 8-Chamber Leg Sleeve - Extra Wide Adjustable GWA-3045-S 4-Chamber Leg Sleeve - Wide Adjustable Small GA-3045-S 4-Chamber Adjustable Leg Sleeve - Small GS-3045-L 4-Chamber Leg Sleeve - Large G8-3035-M 8-Chamber Arm Sleeve - Medium GW8-3045-M 8-Chamber Leg Sleeve - Medium Wide G8-3035-SH-M-L 8-Chamber Arm & Shoulder Sleeve - Medium Left GW8-3045-S 8-Chamber Leg Sleeve - Small Wide G8-3035-SH/L 8-Chamber Arm & Shoulder Sleeve - Large GN-3045-L 4-Chamber Leg Sleeve - Large Narrow GV-3000-8C 8-Chamber Vest GV-3010-S-R Elite 8 Bio Vest - Small Right SC-3004-DL Sequential Circulator GWA-3045-L 4-Chamber Leg Sleeve - Wide Adjustable Large GS-3035-S 4-Chamber Arm Sleeve - Small GN8-3045-S 8-Chamber Leg Sleeve - Small Narrow GN8-3045-M 8-Chamber Leg Sleeve - Medium Narrow GBA-3045-S-L Bio Abdominal - Small Left leg GS-3035-SH-L-R 4-Chamber Arm & Shoulder Sleeve - Large Right G8-3035-SH-S-L 8-Chamber Arm & Shoulder Sleeve - Small Left G8-3035-SH/S 8-Chamber Arm & Shoulder Sleeve - Small G8-3035-SH-S-R 8-Chamber Arm & Shoulder Sleeve - Small Right GWA8-3045-S 8-Chamber Leg Sleeve - Wide Adjustable Small G8-3045-L 8-Chamber Leg Sleeve - Large GS-3045-M 4-Chamber Leg Sleeve - Medium G8-3035-SH-L-L 8-Chamber Arm & Shoulder Sleeve - Large Left GBA-3045-M-2 Bio Pants - Medium SC-3004-DL-230 Sequential Circulator G8-3045-M 8-Chamber Leg Sleeve - Medium GBA-3045-L-2 Bio Pants - Large GWA-3045-M 4-Chamber Leg Sleeve - Wide Adjustable Medium GV-3010-M-R Elite 8 Bio Vest - Medium Right GBA-3045-M-L Bio Abdominal - Medium Left leg GW-3045-L 4-Chamber Leg Sleeve - Large GS-3045-S 4-Chamber Leg Sleeve - Small GS-3045-H 4-Chamber Leg Sleeve - Half G8-3035-SH/M 8-Chamber Arm & Shoulder Sleeve - Medium GN-3045-M 4-Chamber Leg Sleeve - Medium Narrow GXWA-3045 4-Chamber Leg Sleeve - Extra Wide Adjustable

    Establishment Types

    Manufacture Medical Device