VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 08498840007280
• Version / Model: SHY-2234
• Catalog Number: SHY-2234
• Company Name: Vygon Corporation
• Labeler DUNS: 120818216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-16
• Public Version: 4
• Public Version Date: 2019-10-23
• Public Version Status: Update
• Public Device Record Key: f5cf2d64-f197-4b29-915f-dd644d998012

Device Description

10" WINGED SAFETY INFUSION SET WITH 22 GA. X .75" HUBER NEEDLE AND NEEDLELESS Y-SITE

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: Yes
• 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
FPA	Set, administration, intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17701	Vascular port administration set	A collection of devices designed to conduct fluids from an intravenous (IV) fluid container to a patient's venous system via a previously implanted injection/infusion port. It typically includes a noncoring needle designed with a lateral hole (side-hole), tubing, connectors, chambers, clamps and may include an injection placement aid. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	38498840007281	GS1		12	In Commercial Distribution
Primary	08498840007280	GS1
Package	58498840007285	GS1		18	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K020544	000