Integra LPV II Valve Shunt Kit

Basic Information

• Brand Name: Integra LPV II Valve Shunt Kit
• Primary DI: 10381780072485
• Version / Model: NL8509850
• Catalog Number: NL8509850
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-22
• Public Version: 6
• Public Version Date: 2022-10-10
• Public Version Status: Update
• Public Device Record Key: 3a413274-c676-43a5-9530-768aadd7da07

Device Description

STANDARD LPV II SHUNT KIT, MED. The Integra LPV II Valve Shunt Kits are designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. The kit contains a LPV II valve, standard, a Pudenz Ventricular Catheter and an integral, open-ended kink resistant catheter attached to the outlet of the valve. The kit is available in a medium pressure range. All valves and catheters contain barium sulfate for x-ray detectability.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
JXG	Shunt, central nervous system and components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45694	Ventriculoperitoneal shunt	An implantable device intended to divert excessive cerebrospinal fluid (CSF) from the brain ventricles to the peritoneal cavity, where it can be absorbed into the body, as a treatment for increased intracranial pressure (e.g., caused by hydrocephalus). It typically consists of three main connected parts: 1) an intracerebral ventricular catheter through which CSF flows; 2) a mechanical shunt valve that typically opens at a pre-set pressure; and 3) a peritoneal catheter that channels the CSF to the peritoneal cavity. It is made of plastic and silicone materials; disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780072485	GS1
Secondary	M269NL85098501	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K153041	000
K974708	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Valve Length: 36.7mm, Valve Width: 16.7mm, Profile Height: 7.8mm