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510(k) Data Aggregation
K Number
K151503Device Name
NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
Manufacturer
Date Cleared
2016-04-05
(306 days)
Product Code
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
GBUK Enteral Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube device is inserted into the stomach through the nasal cavity for the purpose of supplying a nutritional source for those patients who are unable to feed themselves.
Device Description
The NUTRICARE ISO-SAF™ Naso-gastric Feeding Tube is an enteral feeding tube designed for continuous or intermittent use. It comprises of radio-opaque polyurethane tube with guide wire set and ENFit connector.
The guide wire set is composed of a rigid guide wire and a male threaded connector, which is inserted into the polyurethane tube. They're depth marks printed on the tube in order to provide reference about the depth of insertion to the practitioner.
The tube is to be inserted through the nasal or oral area and feed down into the alimentary canal system (i.e. stomach area, duodenum or small intestine as intended). The guide wire with male connector is removed when the insertion is done leaving the tube and ENFit connector in situ. Only a female ENFit enteral syringe can be attached to the ENFit connector when in use.
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