BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector

    DI: B48312EFT91S1 · Model: 12EFT91S · ENVIZION MEDICAL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    10

    Basic Information

    Brand Name
    ENvue® Enteral Feeding Tube with Stylet and ENFit® Connector
    Primary DI
    B48312EFT91S1
    Version / Model
    12EFT91S
    Catalog Number
    ENV-12091
    Company Name
    ENVIZION MEDICAL LTD
    Labeler DUNS
    531864963
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    10
    Record Status
    Published
    Publish Date
    2022-07-26
    Public Version
    1
    Public Version Date
    2022-08-03
    Public Version Status
    New
    Public Device Record Key
    ed2ee594-b311-4794-9167-6f86e93870f2

    Device Description

    12 French Size, 91 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.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNT Tubes, Gastrointestinal (And Accessories)

    GMDN Terms

    Code Name
    14221 Nasogastric feeding tube

    Identifiers

    Type ID
    Unit of Use B48312EFT91S0
    Primary B48312EFT91S1

    Customer Contacts

    Phone
    860-810-7918
    Email
    [email protected]

    Device Sizes

    Type Value Unit Text
    Catheter Length 91 Centimeter

    Storage Conditions

    Type
    Special Storage Condition, Specify
    Special Conditions
    The Enteral Feeding Tube should be stored in a cool dry place and should be protected from direct sunlight.