AVANOS

Basic Information

• Brand Name: AVANOS
• Primary DI: 00350770458199
• Version / Model: 45819
• Catalog Number: 20-9551TRAK2A
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-15
• Public Version: 1
• Public Version Date: 2020-05-25
• Public Version Status: New
• Public Device Record Key: 9e34cb10-53b1-4921-9ff7-f8b0c716500e

Device Description

CORTRAK* 2 Nasogastric/Nasointestinal Feeding Tube with Electromagnetic Transmitting Stylet

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: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
FPD	TUBE, FEEDING	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59081	Enteral tube tracking system transmitter stylet	A non-sterile, thin, flexible wire with an electromagnetic (EM) transmitter at the distal end that is a component of an enteral tube tracking system and intended to be used as a stylet for an enteral feeding tube with which it is supplied. It is designed to facilitate the placement of the enteral tube by providing a signal used to create a graphic display representing the path of the tube tip. During use it is typically connected to a visual display/control unit and is used with an electromagnetic transmission receiver placed on the epigastrium. This is a reusable device intended for single-patient use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10350770458196	GS1	CS	10	In Commercial Distribution
Primary	00350770458199	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	10	French