Enteral distal end ENFit Transition Connector

Basic Information

• Brand Name: Enteral distal end ENFit Transition Connector
• Primary DI: 08056093720716
• Version / Model: 7149 00
• Company Name: CEDIC SRL
• Labeler DUNS: 429471691
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-20
• Public Version: 4
• Public Version Date: 2020-07-23
• Public Version Status: Update
• Public Device Record Key: bb327f4c-5f8d-4390-9ed3-6a8c4d56b453

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: Labeling does not contain MRI Safety Information
• 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	Medical Specialty	Regulation #	Device Class
PIO	Enteral specific transition connectors	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64469	ENFit/non-ISO80369-standardized linear connector	A small, non-powered, noninvasive, tubular two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, ENLock, threaded or non-Luer-slip), intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection typically with tubing or syringe; it does not connect a vial/bottle (i.e., not a vial/bottle adaptor). It does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056093720716	GS1
Package	08056093720723	GS1		5	In Commercial Distribution
Package	08056093720730	GS1		40	In Commercial Distribution
Package	08056093720747	GS1		24	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]