Foltz Flushing Reservoir

Primary DI
10381780071433
Brand
Foltz Flushing Reservoir
Company
Integra Lifesciences Corporation
Model
NL8501195
Catalog number
NL8501195
Device description
RESERVOIR FLUSHING The silicone elastomer Foltz Flushing Reservoir is a low-profile, flat-bottom, single-dome device utilized for shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The Foltz Flushing Reservoir contains no mechanism to control pressure or to prevent retrograde flow of CSF from the distal to the proximal catheter. Flushing of proximal and distal catheters is accomplished by pumping the reservoir dome while occluding either the proximal or distal catheter with transcutaneous finger pressure. The flat-bottom design eliminates the need for a formal burr hole. It also permits the attachment of dual ventricular catheters by utilizing a three-way connector at the inlet tube.
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
10381780071433PrimaryGS10
M269NL85011951SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007143310381780071433

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid reservoirA sterile, closed system designed to access the cerebral ventricles to drain and collect cerebrospinal fluid to reduce intracranial pressure (ICP). 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
false
Sterilization required before use
false

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