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510(k) Data Aggregation
K Number
K022558Device Name
NGT
Manufacturer
Date Cleared
2003-07-08
(340 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INNOVATIVE PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NGT is intended for gastric decompression, gastric suction, administration of nutritional supplements and medication, and to monitor core temperature.
Device Description
The NGT Nasogastric Tube is made of a plastic material, contains three lumens, a main suction lumen, a smaller vent lumen, and a still smaller temperature thermistor lumen. The primary suction lumen is used for drainage, the second vent lumen provides an air inlet as a mechanism to break suction minimizing the potential for tube blockage secondary to mucosal tissue invagination into the side holes of the primary lumen. The device is intended to be used with a standard suction source to facilitate drainage.
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