VYGON

Basic Information

• Brand Name: VYGON
• Primary DI: 00849884007046
• Version / Model: VYML4D1003-1
• Catalog Number: VYML4D1003-1
• Company Name: Vygon Corporation
• Labeler DUNS: 120818216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-25
• Public Version: 1
• Public Version Date: 2025-10-03
• Public Version Status: New
• Public Device Record Key: afdcf700-996a-4632-a0de-f46d5caef46d

Device Description

4Fr Dual Lumen Midline Basic Kit

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PND	Midline catheter	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10729	Centrally-inserted central venous catheter	A flexible tube intended to be introduced into a neck or thoracic vein and often advanced into the superior vena cava for various infusion/aspiration procedures (i.e., non-dedicated) including the intravenous administration of nutrients, fluids, chemotherapeutic agents or other drugs, and blood sampling or delivery; it may also be used to monitor venous pressure. The proximal end of this central venous catheter (CVC) is typically fixed to the patient for long-term use. It may include supportive devices associated with introduction (e.g., guidewire, introducer); it is not primarily intended for extracorporeal blood therapies such as haemodialysis. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30849884007047	GS1		5	In Commercial Distribution
Primary	00849884007046	GS1

Premarket Submissions

Submission Number	Supplement Number
K181208	000