MoniTorrTM SP0206

GUDID 10381780072003

MONITORR ICP The MoniTorr ICP External CSF Drainage and Monitoring System provides a simple to use, closed system for the drainage of cerebrospinal fluid (CSF) from ventricles of the brain or the lumbar subarachnoid space to a drainage bag. The system may be used with a pole mounted assembly that allows for simple, quick, and accurate alignment with the patient and secure, positive or negative pressure level setting. The system has also been designed to provide for ease of patient transport through a compact design and an antimicrobial hydrophobic vent feature that resists occlusion. Common features include a calibrated graduated burette, a drainage bag, sampling/aspiration sites, and an increased green stripe pressure tubing.

Integra Lifesciences Corporation

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• Primary Device ID: 10381780072003
• NIH Device Record Key: e0483c54-3a0c-46e6-a4b3-0eb9abd66786
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MoniTorrTM
• Version Model Number: SP0206
• Catalog Number: SP0206
• 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: 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: 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	10381780072003 [Primary]
HIBCC	M269SP02061 [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