Integra Flow Regulating Valve Low Flow 9OS502

GUDID 10381780036005

The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve systems for controlled cerebrospinal fluid (CSF) drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart’s right atrium. Unlike conventional valves, the Integra Flow Regulating Valve Low Flow is a variable resistance valve that maintains drainage at a constant rate, between 8 and 17 ml/hr, within the physiological range of intracranial pressure.

INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Ventriculo-peritoneal/atrial shunt

• Primary Device ID: 10381780036005
• NIH Device Record Key: a4b91cc8-3bc9-4850-b1b6-9265fbb80f90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra Flow Regulating Valve Low Flow
• Version Model Number: 9OS502
• Catalog Number: 9OS502
• Company DUNS: 531408342
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
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• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
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Device Dimensions

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Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
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• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
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• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
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• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
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• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room temperature
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• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged
• Special Storage Condition, Specify: Between 0 and 0 *Do Not Use if Package is Damaged

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780036005 [Primary]
HIBCC	M2729OS5021 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042192

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-07
• Device Publish Date: 2015-10-01

On-Brand Devices [Integra Flow Regulating Valve Low Flow]

• 10381780036050: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780036043: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• M2729OS512P1: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780036029: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• M2729OS502P1: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
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• 10381780033899: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033882: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033875: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033868: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033851: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033844: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033837: The Integra Flow Regulating Valves Low Flow Lumbar are implantable hydrocephalus valve systems
• 10381780033820: The Integra Flow Regulating Valves Low Flow Lumbar are implantable hydrocephalus valve systems
• 10381780033813: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033806: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033790: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033783: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033776: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033769: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033752: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033745: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve
• 10381780033738: The Integra Flow Regulating Valves Low Flow (Standard, Mini) are implantable hydrocephalus valve