Ventricular vent catheter

Basic Information

• Brand Name: Ventricular vent catheter
• Primary DI: 00803622106446
• Version / Model: VT-xxxxx
• Company Name: LIVANOVA USA, INC.
• Labeler DUNS: 080914995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-16
• Public Version: 4
• Public Version Date: 2018-08-15
• Public Version Status: Update
• Public Device Record Key: 2623d7be-dd6e-467d-bbda-9d67516d27bd

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 Unsafe
• 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
35891	Heart ventricle cannula	A sterile, rigid or semi-rigid tube designed to be surgically inserted into a cardiac ventricle. This is typically done directly during a surgical procedure and advanced until its distal tip is inside the cardiac ventricle. This device will serve as a channel intended for connection to an external device, such as left or right ventricular assist system. Some types may be used for temporary decompression of the left ventricle. 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	10803622106443	GS1	CASE	10	In Commercial Distribution
Primary	00803622106446	GS1

Premarket Submissions

Submission Number	Supplement Number
K981601	000