Halyard

Basic Information

• Brand Name: Halyard
• Primary DI: 10680651472110
• Version / Model: 47211
• Catalog Number: 20-0952
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-31
• Public Version: 3
• Public Version Date: 2018-11-16
• Public Version Status: Update
• Public Device Record Key: 1508153c-46db-4fac-954c-cb1bbea8d828

Device Description

HALYARD* CORTRAK* 2 Enteral Access System - Smart Receiver Unit

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
59078	Enteral tube tracking system	A mains electricity (AC-powered) portable electronic device assembly, typically with rechargeable battery, designed to detect, record, and display an electromagnetic (EM) signal emitted from a transmitter in an enteral feeding tube stylet to facilitate the placement of the enteral tube, by providing a graphic display representing the path of the tube tip. It consists of an electromagnetic receiver placed on the epigastrium, a visual display/control unit which displays real-time anterior and cross-sectional representational views of the transmitter location and track, and a separately supplied single-use enteral feeding tube stylet which incorporates an electromagnetic transmitter in the tip.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10680651472110	GS1

Customer Contacts

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