Voss Coronary Bypass Vein Flushing Cannula

Basic Information

• Brand Name: Voss Coronary Bypass Vein Flushing Cannula
• Primary DI: 00811304020065
• Version / Model: 82609
• Company Name: VM CARDIO VASCULAR, INC.
• Labeler DUNS: 799240457
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-05
• Public Version: 4
• Public Version Date: 2019-02-21
• Public Version Status: Update
• Public Device Record Key: 4eb93484-336d-47c5-b831-8e713e25159b

Device Description

Vein flushing Cannula for Coronary Bypass (sterile)

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: 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: Yes
• 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
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34896	Vascular irrigation cannula, coronary artery, single-use	A sterile, rigid or semi-rigid tube designed to be surgically inserted, temporarily, into a coronary artery to serve as a channel for the transport of fluid during a surgical intervention. It is typically intended for the infusion and/or perfusion of fluids in diagnostic and/or surgical procedures, such as cardiopulmonary bypass, and to help avoid ischemia. Insertion is achieved with the use of a removable stylet or trocar blade. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811304020065	GS1

Premarket Submissions

Submission Number	Supplement Number
K896338	000