VICI RDS™ Venous Stent System

Basic Information

• Brand Name: VICI RDS™ Venous Stent System
• Primary DI: 00852725008201
• Version / Model: H74912120790
• Catalog Number: H74912120790
• Company Name: Veniti Inc
• Labeler DUNS: 079757164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-15
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 47094da2-40fd-4263-9aae-d065b78df432

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: MR Conditional
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QAN	Stent, iliac vein	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
58057	Iliofemoral vein stent	A non-bioabsorbable tubular device intended to be implanted in an iliac and/or femoral vein to maintain patency in patients with constrained venous outflow. It is inserted and advanced to the site of implantation with a dedicated catheter where it self-expands upon release. The device is typically made of nickel-titanium alloy (Nitinol) and has radiopaque marker(s) for visualization; it is available in a variety of diameters and lengths. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852725008201	GS1

Premarket Submissions

Submission Number	Supplement Number
P180013	004

Device Sizes

Type	Value	Unit	Text
Length	79	Centimeter
Stent Length	120	Millimeter
Stent Diameter	12	Millimeter