Integra LPV II Valve
- Primary DI
- 10381780072447
- Brand
- Integra LPV II Valve
- Company
- Integra Lifesciences Corporation
- Model
- NL8509821
- Catalog number
- NL8509821
- 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.
- 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 |
|---|---|
| JXG | Shunt, central nervous system and components |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | Neurology | 2 |
Premarket Submissions#
Premarket Details#
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|---|---|---|---|---|
| K153041 | 000 | Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling | Integra LifeSciences Corporation | 2016-03-14 | JXG |
| K974708 | 000 | GEMINI STANDARD AND MINI VALVES | Neurocare Group | 1998-03-10 | JXG |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780072447 | Primary | GS1 | 0 | |
| M269NL85098211 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780072447 | 10381780072447 |
GMDN Terms#
| Term | Definition |
|---|---|
| Ventriculo-peritoneal/atrial shunt valve | A 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 |
|---|---|---|
| Device Size Text, specify | 0 |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)654-2873 | custsvcnj@integralife.com |
Regulatory Flags#
- DUNS number
- 083171244
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
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