FDA.reportPublic FDA data

Integra On-Off Flushing Reservoir

Primary DI
10381780071280
Brand
Integra On-Off Flushing Reservoir
Company
Integra Lifesciences Corporation
Model
NL8500150
Catalog number
NL8500150
Device description
The silicone elastomer On-Off Flushing Reservoirs are designed to facilitate the treatment of hydrocephalus when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The flat-bottom design of each device eliminates the need for a formal burr hole, thus providing greater latitude in positioning and allowing the ventricular catheter to be revised without disturbing the flushing reservoir. The On-Off Flushing Reservoir is a system composed of an Occluder, a Flushing Reservoir, and an On-Off Control.
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
10381780071280PrimaryGS10
M269NL85001501SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178007128010381780071280

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
true
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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Primary DI, Brand, Model table
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10381780541394Durepair®62106621062026-03-11
10381780540823Durepair®62110621102026-03-11
10381780541424Durepair®62158621582026-03-11
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05
10381780537182MAYFIELD®A4000A40002025-08-25
M24841C14441MAYFIELD®41C144441C14442018-04-13
M24841C14451MAYFIELD®41C144541C14452018-04-13
M248A1008P1MAYFIELD®A1008PA1008P2018-05-11
M248A1011P1MAYFIELD®A1011PA1011P2018-04-19
M248A1011SRL1MAYFIELD®A1011SRLA1011SRL2018-05-03
M248A1012P1MAYFIELD®A1012PA1012P2018-04-19
M248A1012SRL1MAYFIELD®A1012SRLA1012SRL2018-05-03
M248A1051P1MAYFIELD®A1051PA1051P2018-04-19
M248A1051SRL1MAYFIELD®A1051SRLA1051SRL2018-05-03
M248A1073P1MAYFIELD®A1073PA1073P2018-04-19
M248A1073SRL1MAYFIELD®A1073SRLA1073SRL2018-05-03
M248A1112P1MAYFIELD®A1112PA1112P2018-04-19
M248A1112SRL1MAYFIELD®A1112SRLA1112SRL2018-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00763000422684StrataMR2MEDTRONIC PS MEDICAL, INC.JXG2026-03-13
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B775EVACMRI0PHASORPHASOR HEALTH LLCJXG2025-11-24
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10381780535409CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535416CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535423CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
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10381780535966CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780535980CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536000CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536024CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536048CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536062CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536086CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
10381780536109CODMAN® CERTAS®Integra LifeSciences Switzerland SàrlJXG2025-06-30
B775EVAC0PHASORPHASOR HEALTH LLCJXG2025-06-04
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