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 In this manner, CSF may be withdrawn or other fluid injected into the reservoir.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 table
CodeName
JXGShunt, central nervous system and components

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780024217PrimaryGS10
M269NL85012121SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178002421710381780024217

GMDN Terms#

Term, Definition table
TermDefinition
Intracerebral infusion/drainage catheter, long-termA 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 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
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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