CLS

Basic Information

• Brand Name: CLS
• Primary DI: 00864039000413
• Version / Model: 201006-000
• Company Name: COASTAL LIFE SYSTEMS, INC.
• Labeler DUNS: 610391229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-19
• Public Version: 4
• Public Version Date: 2020-11-02
• Public Version Status: Update
• Public Device Record Key: c0a3fd1b-e430-40b0-9805-22a6a9141102

Device Description

Saphenous Vein Cannula

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: 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
47798	Vascular irrigation cannula, cardiac vessel graft	A sterile, single-lumen, tubular device designed to be used during cardiac surgery to flush an autologous graft, typically a section of explanted saphenous vein, to test its integrity and the closure of lateral vessels, as well as to remove debris and clots after resection. It is typically made of plastic material (e.g., polypropylene) and typically designed with a connector at the proximal end (e.g., is attached to a syringe with a Luer connector) and a ribbed flange at the distal end for a secure connection to the vessel. It may also be used to perfuse the heart through the graft after having done the anastomosis on the coronary artery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10864039000410	GS1		25	In Commercial Distribution
Primary	00864039000413	GS1