Integra Mishler Dual Chamber Flushing Valve
- Primary DI
- 10381780072256
- Brand
- Integra Mishler Dual Chamber Flushing Valve
- Company
- Integra Lifesciences Corporation
- Model
- NL8500312
- Catalog number
- NL8500312
- Device description
- VALVE FLUSH F/B D/C W/CONNECTORThe Integra Mishler Dual Chamber Flushing valve, Flat Bottom Design incorporates two separate interior chambers to provide two-way flow control when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. This silicone elastomer flushing valve is available with or without an integral Anti-Siphon Device. The flat bottom configuration eliminates the need for a formal burr hole, provides greater latitude in positioning the flushing valve and allows the ventricular catheter to be revised without disturbing the flushing valve. Due to the dual chamber feature, the proximal and distal catheters may be flushed separately or simultaneously. The flow of CSF from the ventricular catheter is controlled by a miter valve located on the vertical chamber divider. This valve is designed to open under a medium positive ventricular pressure and close under a negative pressure. The flushing valve dome is marked with an arrow to indicate the CSF flow direction. The flange overlying the skull contains sutural holes to facilitate securing the device to the periosteum.
- 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#
| Submission | Supplement |
|---|---|
| K153041 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780072256 | Primary | GS1 | 0 | |
| M269NL85003121 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780072256 | 10381780072256 |
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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