Integra LPV II Valve NL8509820

GUDID 10381780024446

STANDARD LPV II VALVE, MED. The Integra LVP II Valve, Standard is a silicone elastomer valve used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporates an internal medium pressure valve assembly which is mounted distal to an integral pumping reservoir for proximal control of CSF flow. The device also provides one-way flow control. Integral occluders are incorporated on the proximal and distal end of the valve to allow manual control of flushing or pumping of CSF proximally or distally. The device is fitted with a polypropylene needle guard, designed to prevent inadvertent needle puncture through the base of the reservoir during percutaneous injection. The valve contains an integral plastic connector on each end to simplify the assembly procedure.

Integra Lifesciences Corporation

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• Primary Device ID: 10381780024446
• NIH Device Record Key: afa6d293-cfec-4829-9ded-4037a350e31b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra LPV II Valve
• Version Model Number: NL8509820
• Catalog Number: NL8509820
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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
• 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
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• Email: custsvcnj@integralife.com
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• Email: custsvcnj@integralife.com
• 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
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• Email: custsvcnj@integralife.com
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• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780024446 [Primary]
HIBCC	M269NL85098201 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153041

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: 2020-09-22
• Device Publish Date: 2015-09-22

On-Brand Devices [Integra LPV II Valve]

• 10381780072454: MINI LPV II VALVE, HIGH The Integra LVP II Valve, Mini is a silicone elastomer valve used for th
• 10381780072447: MINI LPV II VALVE, MED. The Integra LVP II Valve, Mini is a silicone elastomer valve used for th
• 10381780072430: STANDARD LPV II VALVE, LOW The Integra LVP II Valve, Standard is a silicone elastomer valve used
• 10381780024446: STANDARD LPV II VALVE, MED. The Integra LVP II Valve, Standard is a silicone elastomer valve use
• 10381780024439: MINI LPV II VALVE, LOW The Integra LVP II Valve, Mini is a silicone elastomer valve used for the