Enteral

Basic Information

• Brand Name: Enteral
• Primary DI: 05060460843970
• Version / Model: EN-PLUG-S
• Catalog Number: EN-PLUG-S
• Company Name: GBUK ENTERAL LIMITED
• Labeler DUNS: 216643186
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-20
• Public Version: 3
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: eb524500-b622-4e6e-9762-4a9d68669917

Device Description

Enteral, Stoma Plug, ENPLUG, Single Patient Use 10, 12, 14, 16Fr x 4cm

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EXE	PROTECTOR, OSTOMY	Gastroenterology, Urology	876.5900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62183	Intestinal/urinary stoma button	A plug-like device intended to be placed in an intestinal and/or urinary stoma to prevent leakage and narrowing (stenosis), typically during intermittent use of an enema catheter/tube. It is in the form of a flanged cylinder and is made of flexible synthetic polymer materials (e.g., silicone). This is a single-patient reusable device after appropriate cleaning/disinfection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060460843987	GS1	Box	100	In Commercial Distribution
Primary	05060460843970	GS1