Integra LPV II Valve

Primary DI
10381780072430
Brand
Integra LPV II Valve
Company
Integra Lifesciences Corporation
Model
NL8509810
Catalog number
NL8509810
Device description
STANDARD LPV II VALVE, LOWThe Integra LVP II Valve, Standard 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 low 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.
Published
2015-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JXGShunt, central nervous system and components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153041000
K974708000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153041000Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation2016-03-14JXG
K974708000GEMINI STANDARD AND MINI VALVESNeurocare Group1998-03-10JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780072430PrimaryGS10
M269NL85098101SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007243010381780072430

GMDN Terms#

Term, Definition table
TermDefinition
Ventriculo-peritoneal/atrial shunt valveA sterile implantable device intended to function as part of a ventriculoperitoneal or ventriculoatrial shunt to regulate the pressure and flow level of cerebrospinal fluid (CSF) from the 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 plastic and silicone materials. It typically opens at a pre-set pressure and may be non-invasively adjusted using a dedicated programmer.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
1
Lot or batch
true
Expiration date on label
true

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