Reference Sensor Clip with Adhesive Patch for use with the ENVizion® ENVue® Syst

FDA UDI

Class II (US FDA UDI)

by Envizion Medical Ltd

Identity

Trade Name: Reference Sensor Clip with Adhesive Patch for use with the ENVizion® ENVue® Syst FDA UDI
Generic Name: Nasogastric feeding tube FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 1RSC01 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: ENV-30000 FDA UDI
Primary DI / UDI-DI: B4831RSC011 FDA UDI
510(k) Number: K203133 FDA UDI
FDA Product Code: KNT FDA UDI
GMDN Term: Nasogastric feeding tube FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5980 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Nasogastric feeding tube

Reference Sensor Clip with Adhesive Patch for use with the ENVizion® ENVue® Syst by Envizion Medical Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Nasogastric feeding tube.

MED-RX — Canadian Hospital Specialties Limited · Class II
NeoDevices, Inc. — NEODEVICES INC · Class II
CORFLO Enteral Feeding Tube — Corpak Medsystems · Class II
VYGON — Vygon Corp. · Class II
Curaplex — BOUND TREE MEDICAL, LLC · Class II
CORFLO Enteral Feeding Tube — Corpak Medsystems · Class II
Enteral — GBUK ENTERAL LIMITED · Class II
NutraGlide Nasal Feeding Tube — Applied Medical Technology, Inc. · Class II

Cleared under the same submission

K203133 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Envizion Medical Ltd

Sources (1)

FDA UDI 1d3f43b3-adfb-4fcd-81e0-3f6ba3416e1f 37 fields · synced May 30, 2026