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510(k) Data Aggregation
K Number
K210570Device 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/AWhy did this record match?
Product Code :
PHU
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).
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K Number
K070201Device Name
BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001
Manufacturer
C.R. BARD, INC.
Date Cleared
2007-08-01
(191 days)
Product Code
PHU, LXC, UNC
Regulation Number
N/AWhy did this record match?
Product Code :
PHU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bard® Intra-abdominal Pressure (IAP) Monitoring Device is intended for the monitoring of intra-abdominal pressure via a Foley urinary catheter. The measured pressures can be used as an aid in the diagnosis of intraabdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS).
Device Description
The Bard® Intra-abdominal Pressure (IAP) Monitoring Device) is composed of a tubing set used for infusing fluid into the urinary bladder through the Foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which intra-abdominal pressure is measured.
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