Halyard

Basic Information

• Brand Name: Halyard
• Primary DI: 10680651258929
• Version / Model: 25892
• Catalog Number: 7123-12
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-01
• Public Version: 2
• Public Version Date: 2019-10-07
• Public Version Status: Update
• Public Device Record Key: b8416b4e-e25a-403c-89a5-25c3837c0346

Device Description

MIC-KEY* SF Bolus Feed Extension Set, 30 cm (12 in.)

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: Yes
• MRI Safety: MR Conditional
• 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: 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
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	30680651258923	GS1	CS	5	In Commercial Distribution
Primary	10680651258929	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K043114	000

Device Sizes

Type	Value	Unit	Text
Length	30	Centimeter