Search Results
Found 1 results
510(k) Data Aggregation
K Number
K082710Device Name
SAFECHILD ENTERAL FEEDING TUBE AND ACCESSORIES AND FEEDING TUBE EXTENSION SET
Manufacturer
NEOCHILD, LLC
Date Cleared
2009-01-23
(129 days)
Product Code
KNT
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
NEOCHILD, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician Intended for nasogastric or orogastric placement Lumited to < 30 day placement Not intended for transpyloric placement
Device Description
The proposed modification to Infant Feeding Tube and accessories is to add additional materials that the feeding tube may be made from, 1 e , silicone and polyurethane In addition, we offer accessories an enteral extension set and syringe with non-IV connector These may be sold with the Feeding tubes or separately There is an option of the connectors being standard IV luer lock or a special non-IV connector which was cleared under K072756
The feeding tubes are a small diameter tube of various diameters, 4, 5, and 8 French, and various lengths They have an integral female fitting There are 2 eyelets near the tup of the tube They have markings along the shaft of the tubing and an integral radiopaque line They are provided sterile We will offer a non-sterile syringe with the appropriate mating, non-IV connector as part of the package, which was also cleared under K072756
Ask a Question
Page 1 of 1