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510(k) Data Aggregation
K Number
K092628Device Name
ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET
Manufacturer
ALAN REID
Date Cleared
2010-05-20
(266 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
ALAN REID
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pediation Enteral Feeding tubes are intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. They are intended for nasogastric or orogastric placement, limited to < 30 day placement and not intended for transpylorie placement.
The Pediatric Enteral Feeding Tube Extension sets are used to provide a connection between feeding formula bag and the feeding tube. Extensions sets are offered in non-IV fittings and IV fittings (which have been marked "For enteral feeding only".
Device Description
The proposed modification to the Pediatric Enteral Feeding Tubes and accessories is to add additional materials that the feeding tube may be made from, i.e., PVC, silicone, and polyurethane. In addition, we offer accessories: an enteral feeding extension set and syringe with non-IV connector. These may be sold with the Enteral Feeding tubes or separately. There is an option of the connectors to be provided as standard IV luer lock or a non-IV connector. In all cases the feeding tube and accessories are marked "For enteral feeding only".
The enteral feeding tubes are provided in various diameters (4, 5, 6.5, 8, 10 Fr) and various lengths. They have an integral female fitting. There are 2 eyelets near the tip of the tube. They have markings along the shaft of the tubing and an integral radiopaque line. They are provided sterile.
The Enteral extension sets are provided in various lengths and various configurations of components.
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