MoniTorrTM
Basic Information
- Brand Name
- MoniTorrTM
- Primary DI
- 10381780071952
- Version / Model
- SP0186
- Catalog Number
- SP0186
- Company Name
- Integra Lifesciences Corporation
- Labeler DUNS
- 083171244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-22
- Public Version
- 5
- Public Version Date
- 2020-09-22
- Public Version Status
- Update
- Public Device Record Key
- 04b8c84f-3f5c-4077-9726-6dac94928124
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JXG | Shunt, central nervous system and components | Neurology | 882.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61798 | Ventricular cerebrospinal fluid drainage catheterization kit | A collection of sterile devices intended for short-term access to the brain ventricles to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes an intracerebral infusion/drainage catheter and devices intended for catheter insertion (e.g. stylet) and CSF collection (e.g., drip chamber, drainage bag, tubing set). This is a single-use device. | No | Active |
| 61797 | Lumbar cerebrospinal fluid drainage catheterization kit | A collection of sterile devices intended for short-term percutaneous access to the subarachnoid (intrathecal) or epidural space of the lumbar spinal column to drain cerebrospinal fluid (CSF), and/or other fluids of similar physical characteristics, as a means of reducing CSF volume and intracranial pressure (ICP). It includes a spinal infusion/drainage catheter and devices intended for catheter insertion (e.g. Tuohy needle, suture, guidewire) and CSF collection (e.g., drip chamber, drainage bag, tubing set, filter). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780071952 | GS1 | ||||
| Secondary | M269SP01861 | HIBCC |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]