EasyFlow Duo Cannula

Basic Information

• Brand Name: EasyFlow Duo Cannula
• Primary DI: 00803622128073
• Version / Model: Duo Cannula
• Company Name: LIVANOVA USA, INC.
• Labeler DUNS: 080914995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-17
• Public Version: 4
• Public Version Date: 2018-08-15
• Public Version Status: Update
• Public Device Record Key: efbd47fb-29e9-454a-ba30-0a25361df8f5

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: 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
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35565	Aorta cannula	A sterile, rigid or semi-rigid tube that is surgically inserted into the aorta, typically through the femoral artery and advanced until its distal tip is inside the abdominal aorta, to serve as a channel for the transport of fluid. It may be used for a variety of purposes, e. g, the injection or withdrawal of substances and/or blood, and commonly for external blood circulation during cardiopulmonary bypass procedures or as an outflow for ventricular assist systems. Insertion is achieved with the use of a removable stylet or trocar. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10803622128070	GS1	CASE	1	In Commercial Distribution
Primary	00803622128073	GS1

Premarket Submissions

Submission Number	Supplement Number
K091542	000