Integra Peritoneal Reflux Control Catheter NL8501375

GUDID 10381780024293

PERITONEAL REFLUX CONTROL CATHETER The Integra Peritoneal Reflux Control Catheter is designed to deliver cerebrospinal fluid (CSF) to the peritoneal cavity with minimum flow resistance. This catheter is recommended for use with pressure control valves located proximally in the hydrocephalic shunt system. This catheter has a series of slits located along the catheter’s distal section. These slits, made up of one set of four slits at the catheter’s distal end and two sets of two slits spaced at 2.5cm intervals along the catheter help resist retrograde flow of CSF while minimizing occlusion at the distal catheter tip. The catheter is made of a high durometer silicone elastomer which helps resist kinking and occlusion caused by the bending or twisting of the catheter. A stripe, made of barium sulfate impregnated silicone elastomer, is imbedded in the wall of the catheter. The distal tip of the catheter is filled with radiopaque tantalum impregnated silicone elastomer. The maximum flow resistance is 50mm H2O at a flow rate of 23 ml/hr.

Integra Lifesciences Corporation

Peritoneal/atrial cerebrospinal fluid catheter

• Primary Device ID: 10381780024293
• NIH Device Record Key: 6d52a528-6ec6-4335-8182-a1f22165d05b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra Peritoneal Reflux Control Catheter
• Version Model Number: NL8501375
• Catalog Number: NL8501375
• 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
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Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780024293 [Primary]
HIBCC	M269NL85013751 [Secondary]

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: 3
• Public Version Date: 2020-09-22
• Device Publish Date: 2016-12-15

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