MoniTorrTM SP0186

GUDID 10381780071952

MONITORR ICP EVD SYSTEM MoniTorr ICP ™ External CSF Drainage and Monitoring System is designed to provide a simple to use, closed system for the drainage of cerebrospinal fluid (CSF), and allow for accurate pressure and flow rate monitoring. The system provides simple, quick and accurate alignment with the patient and secure, accurate positive pressure head setting. The system has also been designed to provide for ease of patient transport through a compact design and a VentGuard™ feature that inhibits contamination of the microbial barrier filter vent. All sampling sites are needeless. A low resistance one-way valve is positioned in the patient line to prevent retrogade flow of CSF during system use. It is not designed to regulate flow.

Integra Lifesciences Corporation

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• Primary Device ID: 10381780071952
• NIH Device Record Key: 04b8c84f-3f5c-4077-9726-6dac94928124
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MoniTorrTM
• Version Model Number: SP0186
• Catalog Number: SP0186
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: 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
• 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	10381780071952 [Primary]
HIBCC	M269SP01861 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022554

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: 5
• Public Version Date: 2020-09-22
• Device Publish Date: 2015-09-22

On-Brand Devices [MoniTorrTM]

• 10381780072560: MONITORR SPECIAL NEEDLE SITE The MoniTorr ICP External CSF Drainage and Monitoring System provid
• 10381780072010: MONITORR ICP EVD SYSTEM MoniTorr ICP External CSF Drainage and Monitoring System provide a simpl
• 10381780072003: MONITORR ICP The MoniTorr ICP External CSF Drainage and Monitoring System provides a simple to u
• 10381780071952: MONITORR ICP EVD SYSTEM MoniTorr ICP ™ External CSF Drainage and Monitoring System is designe
• 10381780071945: MONITORR ICP EVD SYSTEM MoniTorr ICP ™ system allows for drainage and monitoring of CSF from
• 10381780071938: MONITORR ICP EVD SYSTEM MoniTorr ICP ™ system allows for drainage and monitoring of CSF from
• 10381780071921: MONITORR ICP EVD SYSTEM MoniTorr ICP ™ system allows for drainage and monitoring of CSF from
• 10381780071914: MONITORR ICP EVD SYSTEM MoniTorr ICP ™ system allows for drainage and monitoring of CSF from
• 10381780071891: MONITORR ICP EVD SYSTEM MoniTorr ICP ™ system allows for drainage and monitoring of CSF from