ENVue® System ENV-20000

GUDID B483EVN200000

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.

ENVIZION MEDICAL LTD

Nasogastric feeding tube

• Primary Device ID: B483EVN200000
• NIH Device Record Key: 2f87c5f8-117a-4c52-941f-e2f9d439b074
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENVue® System
• Version Model Number: ENV-20000
• Catalog Number: ENV-20000
• Company DUNS: 531864963
• Company Name: ENVIZION MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 860-810-7918
• Email: jwojculewicz@erigroup.com
• Phone: 860-810-7918
• Email: jwojculewicz@erigroup.com
• Phone: 860-810-7918
• Email: jwojculewicz@erigroup.com
• Phone: 860-810-7918
• Email: jwojculewicz@erigroup.com
• Phone: 860-810-7918
• Email: jwojculewicz@erigroup.com
• Phone: 860-810-7918
• Email: jwojculewicz@erigroup.com
• Phone: 860-810-7918
• Email: jwojculewicz@erigroup.com
• Phone: 860-810-7918
• Email: jwojculewicz@erigroup.com
• Phone: 860-810-7918
• Email: jwojculewicz@erigroup.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The System should be stored in a cool dry place and should be protected from direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *The System should be stored in a cool dry place and should be protected from direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *The System should be stored in a cool dry place and should be protected from direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *The System should be stored in a cool dry place and should be protected from direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *The System should be stored in a cool dry place and should be protected from direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *The System should be stored in a cool dry place and should be protected from direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *The System should be stored in a cool dry place and should be protected from direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *The System should be stored in a cool dry place and should be protected from direct sunlight.
• Special Storage Condition, Specify: Between 0 and 0 *The System should be stored in a cool dry place and should be protected from direct sunlight.

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B483EVN200000 [Primary]

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-03
• Device Publish Date: 2022-07-26

Devices Manufactured by ENVIZION MEDICAL LTD

• B483ENV20100 - Envue(r) System: 2023-07-10 For full information, Envue System User Manual (6100-1) and IFU (6201-01) OVERVIEW OF SYSTEM The ENvizion Medical ENvue System i
• B48308EFT91S0 - ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector: 2022-08-03 8 French Units, 91 cm For full information, Envue System User Manual (6100-1) and IFU (6201-01) OVERVIEW OF SYSTEM The ENvizion
• B48310EFT140S0 - ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector: 2022-08-03 10 French Size, 140 cm For full information, Envue System User Manual (6100-1) and IFU (6201-01) OVERVIEW OF SYSTEM The ENvizion
• B48310EFT91S0 - ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector: 2022-08-03 10 French units, 91 cm For full information, Envue System User Manual (6100-1) and IFU (6201-01) OVERVIEW OF SYSTEM The ENvizion
• B48312EFT140S0 - ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector: 2022-08-03 12 French Size, 140 cm For full information, Envue System User Manual (6100-1) and IFU (6201-01) OVERVIEW OF SYSTEM The ENvizion
• B48312EFT91S0 - ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector: 2022-08-03 12 French Size, 91 cm For full information, Envue System User Manual (6100-1) and IFU (6201-01) OVERVIEW OF SYSTEM The ENvizion
• B4831RSC010 - Reference Sensor Clip with Adhesive Patch for use with the ENVizion® ENVue® Syst: 2022-08-03 For full information, Envue System User Manual (6100-1) and IFU (6201-01) OVERVIEW OF SYSTEM The ENvizion Medical ENvue System i
• B483EVN200000 - ENVue® System: 2022-08-03For 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.
• B483EVN200000 - ENVue® System: 2022-08-03 For full information, Envue System User Manual (6100-1) and IFU (6201-01) OVERVIEW OF SYSTEM The ENvizion Medical ENvue System i