BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TraumaGuard Intra Abdominal Pressure Monitoring System

    Reg #: 3021468326 · FEI: 3021468326 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    SENTINEL MEDICAL TECHNOLOGIES, LLC
    Registration Number
    3021468326
    FEI Number
    3021468326
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    50 N Laura St Ste 2500
    City
    Jacksonville
    State
    FL
    ZIP
    32202
    Country
    US

    Regulatory Submissions

    510(k) Number
    K240057

    Owner / Operator

    Firm Name
    Sentinel Medical Technologies, LLC
    Operator Number
    10083817
    Address
    50 N Laura Dr, Suite 2500
    City
    Jacksonville
    State
    FL
    Postal Code
    32202
    Country
    US
    Correspondent
    Jackelyn Rodriguez

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL
    Intra-Abdominal Pressure Monitoring Device PHU

    Proprietary Names

    TraumaGuard Intra Abdominal Pressure Monitoring System

    Establishment Types

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