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Intended Use: DoubleCHEK is intended to indicate whether the tip of a naso/oro gastric tube tip is in an acidic or CO2 environment during or after initial placement. The DoubleCHEK is NOT intended to confirm the location of the naso/oro gastric tube. Indications for Use: The DoubleCHEK is indicated for use with an in-situ naso/oro gatric tube. It is intended to indicate whether the tip of a naso/oro gastric tube is in an acidic or CO2 environment during or after initial placement. It is NOT intended to confirm the location of the naso/oro gastric tube. The device is intended to be used by Health Care Professionals on all patients within a health care setting. The device is intended to be used with a single patient for up to 24 hours.

The proposed device, DoubleCHEK DC-1001 is a hand-held, non-powered disposable device which consists of CO2 and pH chambers ultrasonically welded to the device upper (top) and the reservoir interface. pH and CO2 indicator papers are integrated into the design directly underneath the top so they are visible to the users next to the primary device label which contains the color scale. There are three ports where accessories are intended to the device to enable use: - The Syringe Port: A male ENFit connector designed per ISO 80369-3:2016. - The NG Tube (NGT) Port: A female ENFit connector designed per ISO 80369-3:2016. - The Reservoir Interface: A 22 mm bung style connector. To use the proposed device, the user attaches the reservoir to the reservoir interface, the naso/orogastric tube to the NGT Port and the syringe to the Syringe Port. The user then pumps the syringe (withdraws the plunger) to aspirate either liquid (stomach contents) or gas (exhalation gas). The gaseous aspirate will traverse the sample pathway to the CO2 indicator paper, where the presence or absence of CO2 can be detected via a color change in the paper. The liquid aspirate will traverse through the sample pathway to the pH paper, which will indicate pH level via a color change in the paper.