Integra UltraVS In-Line Valve System NL8501128

GUDID 10381780071402

ULTRA VS NEONATAL VALVE W/I H.P. The Integra UltraVS In-Line Valve is a silicone elastomer device used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. The valve incorporate s a unidirectional miter type silicone valve element enclosed in a silicone elastomer sheath. This valve has a high pressure of 95-150mm H2O closing pressure. The Neonate Model UltraVS In-Line Valve offers pressure performance identical to the Standard Model, but has a maximum diameter of less than 4mm and an overall length of less than 12mm, making it ideal for patients requiring the lowest profile valve. Due to the small profile, the neonate model cannot be pumped.

Integra Lifesciences Corporation

Ventriculo-peritoneal/atrial shunt valve

• Primary Device ID: 10381780071402
• NIH Device Record Key: 6f1544f8-a896-4306-938b-4f604427b731
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra UltraVS In-Line Valve System
• Version Model Number: NL8501128
• Catalog Number: NL8501128
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780071402 [Primary]
HIBCC	M269NL85011281 [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 UltraVS In-Line Valve System]

• 10381780071419: ULTRA VS MP W/LRGE RE The Integra UltraVS In-Line Valve is a silicone elastomer device used for
• 10381780071402: ULTRA VS NEONATAL VALVE W/I H.P. The Integra UltraVS In-Line Valve is a silicone elastomer devic
• 10381780071396: ULTRA VS NEONATAL VALVE W/I M.P. The Integra UltraVS In-Line Valve is a silicone elastomer devic
• 10381780071389: ULTRA VS NEONATAL VALVE W/I L.P. The Integra UltraVS In-Line Valve is a silicone elastomer devic
• 10381780071372: ULTRA VS W/RESERVOIR & CATHETER The Integra UltraVS In-Line Valve is a silicone elastomer devic
• 10381780071365: ULTRA VS W/RESERVOIR & CATHETER The Integra UltraVS In-Line Valve is a silicone elastomer devic
• 10381780071358: ULTRA VS W/RESERVOIR & CATHETER L.P. The Integra UltraVS In-Line Valve is a silicone elastomer d
• 10381780071341: ULTRA VS W/RES & CA, H.P. The Integra UltraVS In-Line Valve is a silicone elastomer device used
• 10381780071334: ULTRA VS W/RES & CA, M.P. The Integra UltraVS In-Line Valve is a silicone elastomer device used
• 10381780071327: ULTRA VS W/RES & CA, L.P. The Integra UltraVS In-Line Valve is a silicone elastomer device used
• 10381780071310: ULTRA VS ADULT W/INT The Integra UltraVS In-Line Valve is a silicone elastomer device used for t
• 10381780071303: ULTRA VS ADULT W/INT The Integra UltraVS In-Line Valve is a silicone elastomer device used for t
• 10381780024170: RESERVOIR ONLY, LARGE ULTRA VS The large reservoir consists of a dome, manufactured from barium-
• 10381780024163: ULTRA VS RESERVOIR ONLY, SMALL The small reservoir consists of a dome, manufactured from barium-