Luer to ENFit Transition Connector

Basic Information

• Brand Name: Luer to ENFit Transition Connector
• Primary DI: 08056093720051
• Version / Model: F00128
• Company Name: CEDIC SRL
• Labeler DUNS: 429471691
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-28
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: dc2f679c-2838-4a9d-a595-ac1311308f2f

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
61182	Enteral feeding/medication connector, non-sterile	A non-sterile adaptor intended to enable connection of components of an enteral feeding and/or enteral medication administration kit (e.g., connection between tubing and syringe). It is typically a small plastic device containing a lumen to facilitate enteral administration after connection; it has no additional functionality and is dedicated to enteral administration applications. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08056093720075	GS1		80	In Commercial Distribution
Package	08056093720068	GS1		30	In Commercial Distribution
Primary	08056093720051	GS1

Premarket Submissions

Submission Number	Supplement Number
K162254	000