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The TRIP® Tonometry Catheter, 8F is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric or colonic mucosal tissue when used as a gastrointestinal tract access device for connecting a Tonocap™ monitor (Regional and Airway capnometer) . The sampling line and biofitter built into the device serve as a means of connecting the catheter to the monitor and as transducer protector to prevent patient cross-contamination and monitor damage, respectively. It incorporates a second lumen used for feeding and/or decompression or aspiration of the contents of the stomach or colon.

It is indicated for use in surgical/operating room patients, intensive care unit patients , emergency/trauma patients and hospital patients with suspected mesenteric ischemia.

The TRIP® Tonometry Catheter, 8F is used for the determination of regional PCO2 (PrCO2) and intramucosal pH (pHi) of the gastric or colonic mucosal tissue when used as a gastrointestinal tract access device for connecting a Tonocap™ monitor (Regional and Airway capnometer) . The sampling line and biofitter built into the device serve as a means of connecting the catheter to the monitor and as transducer protector to prevent patient cross-contamination and monitor damage, respectively. It incorporates a second lumen used for feeding and/or decompression or aspiration of the contents of the stomach or colon.

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "TRIP® Tonometry Catheter, 8F". It describes the device's intended use and FDA's determination of substantial equivalence to predicate devices.

However, this document does not contain any information about acceptance criteria or a study proving the device meets said criteria. It is a regulatory notification, not a technical report or study summary. Therefore, I cannot extract the requested information from the provided text.

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