AVANOS

Basic Information

• Brand Name: AVANOS
• Primary DI: 00350770000053
• Version / Model: 00005
• Catalog Number: RA-0016
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-05-08
• Public Version: 1
• Public Version Date: 2020-05-18
• Public Version Status: New
• Public Device Record Key: 4a9689f5-56ea-40da-a66f-af4bb111703c

Device Description

CORFLO* PEG Fixation Device Base and Cover

Device Characteristics

• Single Use: Yes
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
PLI	Gastrointestional Tube Holder	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64461	Enteral feeding noninvasive-component set	A collection of devices such as tubing, connectors, chambers, clamps, and bags/bottles intended to be used to create the noninvasive (i.e., fully external) portion of an enteral feeding device assembly; it is not intended for intravenous (IV) administration. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10350770000029	GS1
Primary	00350770000053	GS1

Customer Contacts

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