ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector
Primary DI
B48312EFT140S0
Brand
ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector
Company
ENVIZION MEDICAL LTD
Model
12EFT140S
Catalog number
ENV-12140
Device description
12 French Size, 140 cm For full information, Envue System User Manual (6100-1) and IFU (6201-01) OVERVIEW OF SYSTEM The ENvizion Medical ENvue System is an electromagnetic sensing device designed to aid qualified operators in the placement of the ENvizion Enteral Feeding Tube (EFT) into the stomach or small intestine of patients requiring enteral feeding. The ENvizion ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes, prior to commencing the delivery of enteral nutrition. Although this System has been designed to exacting specifications, it is not intended to replace trained personnel in the supervision of feeding tube placements. Only clinical personnel familiar with the placement of oro/nasoenteric tubes should perform tube placements. As placement is performed, the all-in-one PC displays the relative tip position and track. The entire placement is recorded and may be replayed later. The ENvizion Enteral Feeding Tube’s position must be confirmed per institution protocol (i.e., X- ray, pH measurement, etc.). 3. CONDITIONS FOR USE 3.1. INDICATIONS FOR USE The ENvizion Medical ENvue System is designed to aid qualified operators in the placement of the ENvizion Medical Enteral Feeding Tube of 8 Fr to 12 Fr into the stomach or small intestine of adult patients requiring enteral feeding. The ENvizion Medical ENvue System is intended as an adjunct to current placement practices for assisting clinical practitioners who place feeding tubes. The ENvizion Medical Enteral Feeding Tube (EFT) has been specifically designed for use with the ENvue System and is intended for placement in the stomach or small intestine. It is intended for use in adult patients who require intermittent or continuous feeding via the oro/nasoenteric route. The EFT is intended only to be used with a feeding pump and is not compatible with gravity-based feeding bags.
A sterile, thin, flexible, hollow cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily for enteral feeding and the administration of medications, either by gravity or with a pump; it may also be used for aspiration of gastric contents (e.g., gastric secretions). It is typically a single lumen, rubber or plastic tube of various diameters (typically smaller than those of nasogastric tubes intended primarily for decompression) with circular markings that serve as insertion guides. It is frequently used for very ill or comatose patients. This is a single-use device.
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