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510(k) Data Aggregation
K Number
K180236Device Name
VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
Manufacturer
VR MEDICAL TECHNOLOGY CO., LTD
Date Cleared
2019-01-18
(354 days)
Product Code
FPD, KNT, PIF
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
VR MEDICAL TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.
The Enteral Feeding Extension Set (EFES) is intended for use as an extension set for nasogastric / oralgastric or gastric tube enteral feeding tubes, incorporating safety connectors/small bore connectors which are intended to reduce the misconnection between the following applications: I.V. system and Enteral Feeding System.
The EFES is indicated for use in neonatal and pediatric patients in connection with an enteral feeding tube to provide nutrition via nasal or oral gastric placements.
Device Description
The VR Medical Feeding Tube is intended for nasogastric delivery of various types of liquid nutritional media through the qastro intestinal tract of neonatal, pediatric and is not intended for use beyond 30 days. They are sterile, individually packaged. The orange color coding provides easy visual recognition of the enteral connection. They are designed with a radiopague stripe for X-ray visualization to confirm proper feeding tube placement. They are marked with French size and markings to assist tube placement or check for migration. A tethered plug for connector closure is incorporated when not in use.
The Enteral Feeding Extension Sets ("EFES") are intended to provide access from the feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in multiple configurations: with and without an in-line Y port and lengths. The EFES are sterile disposable device for single patient use only. The EFES is designed to connect existing feeding tubes (nasogastric, gastric, etc.) to various delivery enteral syringes as well as to help minimize the potential for inadvertent delivery of enteral feedings through the intravenous route. i.e., the device cannot be connected to a luer connector. The EFES consists of flexible tubing with an orange strip for easy quick identification of enteral feeding lines as well as a "For Enteral Feeding Only" tag and a slide clamp to provide the additional safety assurance for connection errors.
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