CORFLO* 2-Port Y Extension Set with ENFit® Connectors

Basic Information

• Brand Name: CORFLO* 2-Port Y Extension Set with ENFit® Connectors
• Primary DI: 00350770459943
• Version / Model: 40-1007
• Catalog Number: 40-1007
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-20
• Public Version: 2
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: 0a5e8820-cee1-45cd-b5bf-21a0b8e51f70

Device Description

CORFLO* Extension Sets

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: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KNT	Tubes, gastrointestinal (and accessories)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62256	Enteral tube extension	A thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. It is typically a single-lumen, rubber or plastic tube of various diameters/lengths. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10350770459940	GS1	CS	30	In Commercial Distribution
Primary	00350770459943	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K840656	000