Vacuum Relief Check Valve

Basic Information

• Brand Name: Vacuum Relief Check Valve
• Primary DI: 00803622123412
• Version / Model: Vacuum Relief Check Valve
• Company Name: LIVANOVA USA, INC.
• Labeler DUNS: 080914995
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-05-01
• Public Version: 4
• Public Version Date: 2018-08-15
• Public Version Status: Update
• Public Device Record Key: b2f20b05-58ec-48ba-a3df-14e5cf0238ec

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
MJJ	Cpb check valve, retrograde flow, in-line	Cardiovascular	870.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35338	Arteriovenous/external shunt connector	A device designed to connect an arteriovenous (AV) or external shunt to the tubing of an extracorporeal blood circuit, typically part of a haemodialysis system, for withdrawal/infusion of blood. It is typically made of plastic or metal and Y-shaped, allowing alternate withdrawal and infusion of blood. The device is intended to perform haemodialysis using the single-needle/single-lumen needle technique. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10803622123419	GS1	CASE	20	In Commercial Distribution
Primary	00803622123412	GS1

Premarket Submissions

Submission Number	Supplement Number
K982406	000