VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 00849884003154
• Version / Model: AMS-8186CP
• Catalog Number: AMS-8186CP
• Company Name: Vygon Corporation
• Labeler DUNS: 120818216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-27
• Public Version: 1
• Public Version Date: 2020-04-06
• Public Version Status: New
• Public Device Record Key: 0c675f42-4841-4114-9294-0d56c6f97012

Device Description

MIDLINE CATHETER PREP TRAY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
OFK	Percutaneous atrial catheter kit	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61630	Haemodialysis/central venous catheterization kit	A collection of sterile devices and materials intended to be used for short-term (< 30 days) venous access during haemodialysis, by: 1) conducting blood from a patient and returning it after extracorporeal circulation, primarily during haemodialysis, but may also be intended for haemoperfusion and/or apheresis; and 2) enabling central venous access for intravenous (IV) administration and/or invasive venous blood pressure monitoring. It includes a nonimplantable triple-lumen haemodialysis catheter, devices dedicated to catheter introduction/function (e.g., introducer needle, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30849884003155	GS1		20	In Commercial Distribution
Primary	00849884003154	GS1