Integra™ CSF Reservoir
- Primary DI
- M269NL85012121
- Brand
- Integra™ CSF Reservoir
- Company
- Integra Lifesciences Corporation
- Model
- NL8501212
- Catalog number
- NL8501212
- Device description
- RESERVOIR INTEGRA S/I 2.5 W/CONNECTOR The silicone elastomer Integra CSF Reservoir, in connection with a ventricular catheter, is designed to provide access to the brain and/or cerebrospinal fluid (CSF). Access is obtained by penetrating the reservoir dome with a 25-gauge or smaller needle. In this manner, CSF may be withdrawn or other fluid injected into the reservoir. The side inlet reservoir’s inlet tubing enters from the side of the reservoir rather than from the base. This flat bottom side inlet design eliminates the need for a formal burr hole, provides greater latitude in positioning and allows the ventricular catheter to be revised without disturbing the reservoir. A right-angle connector is supplied with the reservoir.
- Published
- 2016-12-15
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Conditional
- Rx
- true
- OTC
- false
- 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 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10381780024217 | Primary | GS1 | 0 | |
| M269NL85012121 | Secondary | HIBCC | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|---|
| 10381780024217 | 10381780024217 |
GMDN Terms#
| Term | Definition |
|---|---|
| Intracerebral infusion/drainage catheter, long-term | A sterile, flexible tube intended to be surgically inserted through the skull for long-term (> 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, catheter holder); it does not include a sensor. This is a single-use device. |
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
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
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