AccessGUDID - DEVICE: Integra LPV II Valve (10381780072447)

GUDID

Device Identifier (DI) Information

Brand Name: Integra LPV II Valve
Version or Model: NL8509821
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: NL8509821
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780072447
Issuing Agency: GS1
Commercial Distribution End Date: December 04, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device Description: MINI LPV II VALVE, MED. The Integra LVP II Valve, Mini is a silicone elastomer valve used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporates an internal medium pressure valve assembly which is mounted distal to an integral pumping reservoir for proximal control of CSF flow. The device also provides one-way flow control. Integral occluders are incorporated on the proximal and distal end of the valve to allow manual control of flushing or pumping of CSF proximally or distally. The device is fitted with a polypropylene needle guard, designed to prevent inadvertent needle puncture through the base of the reservoir during percutaneous injection. The valve contains an integral plastic connector on each end to simplify the assembly procedure.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35965	Cerebrospinal fluid shunt valve	An implantable device intended to function as part of a lumboperitoneal, ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the lumbar spine or brain to the peritoneum/heart right atrium in the management of increased intracranial pressure (e.g., caused by hydrocephalus). It consists of a mechanical valve with catheter connections and is made of synthetic polymer and/or metallic materials; it does not incorporate a port or reservoir. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JXG	Shunt, central nervous system and components

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153041	000
K974708	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Valve length: 30.3 mm; Valve Width: 13.0 mm; Profile Height: 6.0 mm

Device Record Status

Public Device Record Key: 7b834f7d-3ea8-4d25-ab45-e47099954c22
Public Version Date: March 18, 2024
Public Version Number: 6
DI Record Publish Date: September 22, 2015