AVANOS

Basic Information

• Brand Name: AVANOS
• Primary DI: 00350770984605
• Version / Model: 98460
• Catalog Number: 98460
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-08
• Public Version: 2
• Public Version Date: 2019-10-07
• Public Version Status: Update
• Public Device Record Key: 33452b66-48ca-4b2b-a9aa-f1ab08e150ad

Device Description

MIC-KEY* Over-the-Wire Stoma Measuring Device

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGC	TUBE, GASTRO-ENTEROSTOMY	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38565	Gastrostomy button	A sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10350770984602	GS1	CS	10	In Commercial Distribution
Primary	00350770984605	GS1

Customer Contacts

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