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510(k) Data Aggregation

    K Number
    K240057
    Device Name
    TraumaGuard Intra-abdominal Pressure Sensing System
    Manufacturer
    Sentinel Medical Technologies, LLC
    Date Cleared
    2024-04-17

    (100 days)

    Product Code
    EZL, PHU
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sentinel Medical Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TraumaGuard Intra-abdominal Pressure Sensing System is intended for use in the drainage of urine for continuous measuring of intraabdominal pressure (IAP) and core body temperature (CBT). The measured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS).
    Device Description
    The TraumaGuard Intra-abdominal Pressure Sensing System is comprised of a catheter and cable used to connect to standard biometric monitors. The catheter is a Foley catheter that provides continuous biometric monitoring of intra-abdominal pressure and core body temperature. TraumaGuard (TG) is a silicone catheter with two polyurethane pressure sensing balloons used to detect changes in intra-abdominal pressure (IAP), the outer distal balloon and the inner sensing balloon. The outer balloon is filled with 2.0 - 2.5cc of sterile water to ensure contact with the bladder wall. The inner sensing balloon has a column of air that runs the entire length of the catheter from the middle of the outer sensing balloon to a connector on the hub. Temperature can be displayed in Celsius or Fahrenheit and is accurate within ±1°C over a range of 25°C to 40°C (77°F to 104°F). Pressure displayed is between 0mmHg and 40mmHg. The inflation, drainage and sensing ports of the catheter are color-coded and can be operated with a Luer Lock syringe tip. Each TG is sterile and individually pouched. TG Cables are reusable. TG is a single use catheter intended for short-term use (no more than 30 days).
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    K Number
    K210570
    Device Name
    TraumaGuard Intra-abdominal Pressure Sensing System
    Manufacturer
    Sentinel Medical Technologies, LLC
    Date Cleared
    2021-10-29

    (245 days)

    Product Code
    PHU
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sentinel Medical Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TraumaGuard Intra-abdominal Pressure Sensing System is intended for use in the drainage of urine for continuous measuring of intraabdominal pressure (IAP) and core body temperature (CBT). The measured IAP can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS).
    Device Description
    The TraumaGuard Intra-abdominal Pressure Sensing System is comprised of a catheter and cable used to connect to standard biometric monitors. The catheter is a Foley catheter that provides continuous biometric monitoring of intra-abdominal pressure and core body temperature. TraumaGuard (TG) is a silicone catheter with two polyurethane pressure sensing balloons used to detect changes in intra-abdominal pressure (IAP), the outer distal balloon and the inner sensing balloon. The outer balloon is filled with 2.0 - 2.5cc of sterile water to ensure contact with the bladder wall. The inner sensing balloon has a column of air that runs the entire length of the catheter from the middle of the outer sensing balloon to a connector on the hub. Temperature can be displayed in Celsius or Fahrenheit and is accurate within ±1°C over a range of 25°C to 40°C (77°F to 104°F). Pressure displayed is between 0mmHg and 40mmHg. The inflation, drainage and sensing ports of the catheter are color-coded and can be operated with a Luer Lock syringe tip. Each TG is sterile and individually pouched. The TG Cables are reusable. TG is a single use catheter intended for short-term use (no more than 30 days).
    Ask a Question

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