Identity
- Trade Name
- MoniTorrTM FDA UDI
- Generic Name
- Ventricular cerebrospinal fluid drainage catheterization kit FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- SP0186 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- SP0186 FDA UDI
- Primary DI / UDI-DI
- 10381780071952 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
Yes
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 04b8c84f-3f5c-4077-9726-6dac94928124 36 fields · synced Jun 8, 2026