Identity
- Trade Name
- MoniTorrTM FDA UDI
- Generic Name
- Ventricular cerebrospinal fluid drainage catheterization kit FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SP0206 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- SP0206 FDA UDI
- Primary DI / UDI-DI
- 10381780072003 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Ventricular cerebrospinal fluid drainage catheterization kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Lumbar cerebrospinal fluid drainage catheterization kitVentricular cerebrospinal fluid drainage catheterization kit
MoniTorrTM by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K022554 also covers:
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ Drainage Bag — Integra Lifesciences Corp.
- MoniTorr ICP™ Drainage Bag with Anti-Reflux Valve — Integra Lifesciences Corp.
- MoniTorr ICP™ External CSF Drainage System — Integra Lifesciences Corp.
- MoniTorrTM — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
K062599 also covers:
- BioPatch® — Integra Lifesciences Corp.
- Evolution™ — Integra Lifesciences Corp.
- Evolution™ — Integra Lifesciences Corp.
- Evolution™ — Integra Lifesciences Corp.
- Hermetic™ — Integra Lifesciences Corp.
- Integra® — Integra Lifesciences Corp.
- Integra™ MoniTorr ICP™ — Integra Lifesciences Corp.
- Integra™ MoniTorr ICP™ — Integra Lifesciences Corp.
- Integra™ MoniTorr ICP™ — Integra Lifesciences Corp.
- LimiTorr™ — Integra Lifesciences Corp.
- LimiTorr™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
K920156 also covers:
- Integra™ Pole Mount Spare Parts Kit — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ — Integra Lifesciences Corp.
- MoniTorr ICP™ Drainage Bag — Integra Lifesciences Corp.
- MoniTorr ICP™ Drainage Bag with Anti-Reflux Valve — Integra Lifesciences Corp.
- MoniTorr ICP™ External CSF Drainage System — Integra Lifesciences Corp.
- MoniTorrTM — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
- MoniTorr™ — Integra Lifesciences Corp.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Integra Lifesciences Corp.
Sources (1)
- FDA UDI e0483c54-3a0c-46e6-a4b3-0eb9abd66786 36 fields · synced May 30, 2026