Identity
- Trade Name
- AccuDrain® FDA UDI
- Generic Name
- Lumbar cerebrospinal fluid drainage catheterization kit FDA UDI
- Device Name
- The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space to a drainage bag. System components facilitate CSF drainage, CSF sampling and intracranial pressure (ICP) monitoring. Monitoring of intracranial pressure (ICP) is usually performed in selected patients with severe head injury, subarachnoid hemorrhage, Reyes syndrome or similar encephalopathies, hydrocephalus, hydrocephalic shunt infections, intracranial hemorrhage and pre and/or post-operative monitoring. FDA UDI
- Model / Reference
- SP0220 FDA UDI
- Description
- The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space to a drainage bag. System components facilitate CSF drainage, CSF sampling and intracranial pressure (ICP) monitoring. Monitoring of intracranial pressure (ICP) is usually performed in selected patients with severe head injury, subarachnoid hemorrhage, Reyes syndrome or similar encephalopathies, hydrocephalus, hydrocephalic shunt infections, intracranial hemorrhage and pre and/or post-operative monitoring. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10381780374121 FDA UDI
- 510(k) Number
- K042825 FDA UDI
- FDA Product Code
- JXG FDA UDI
- GMDN Term
- Lumbar 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
MR Safe FDA UDI
Category: Lumbar cerebrospinal fluid drainage catheterization kitVentricular cerebrospinal fluid drainage catheterization kit
AccuDrain® 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
K042825 also covers:
- AccuDrain® — Integra Lifesciences Corp.
- AccuDrain® — Integra Lifesciences Corp.
- AccuDrain® — Integra Lifesciences Corp.
- AccuDrain® — Integra Lifesciences Corp.
- AccuDrain® — Integra Lifesciences Corp.
- AccuDrain® External CSF Drainage System — Integra Lifesciences Corp.
- AccuDrain® External CSF Drainage System — Integra Lifesciences Corp.
- AccuDrain® External CSF Drainage System — Integra Lifesciences Corp.
- AccuDrain® External CSF Drainage System — Integra Lifesciences Corp.
- AccuDrain® External CSF Drainage System — Integra Lifesciences Corp.
- AccuDrain® External CSF Drainage System — Integra Lifesciences Corp.
- AccuDrain® External CSF Drainage System — 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 6680a256-641f-4344-8173-d48bd4e2f8b9 36 fields · synced May 30, 2026