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AccuDrain® External CSF Drainage System

FDA UDI

Class II (US FDA UDI)

by Integra Lifesciences Corp.

Identity

Trade Name
AccuDrain® External CSF Drainage System 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. Common features to the System include a closed sterile fluid path, calibrated 75mL graduated burette stopcock, 700mL drainage bag, anti-microbial hydrophobic vent, two needleless sampling sites, a patient stopcock, a four way high flow burette stopcock, cord suspension, red burette height indicator, and integral attachment feature. A line level or laser device can be attached. The transparent graduated burette provides visualization of the flow and clarity of the CSF, and allows for volumetric readings to be made prior to fluid entering the drainage bag. FDA UDI
Model / Reference
SP0213 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. Common features to the System include a closed sterile fluid path, calibrated 75mL graduated burette stopcock, 700mL drainage bag, anti-microbial hydrophobic vent, two needleless sampling sites, a patient stopcock, a four way high flow burette stopcock, cord suspension, red burette height indicator, and integral attachment feature. A line level or laser device can be attached. The transparent graduated burette provides visualization of the flow and clarity of the CSF, and allows for volumetric readings to be made prior to fluid entering the drainage bag. FDA UDI

Identifiers

Catalog Number
SP0213 FDA UDI
Primary DI / UDI-DI
10381780072041 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
MRI Safety
MR Safe FDA UDI

Category: Lumbar cerebrospinal fluid drainage catheterization kitVentricular cerebrospinal fluid drainage catheterization kit

AccuDrain® External CSF Drainage System by Integra Lifesciences Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ventricular cerebrospinal fluid drainage catheterization kit.

Cleared under the same submission

K042825 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integra Lifesciences Corp.

Sources (1)

  • FDA UDI e87cd44d-2221-4ead-801d-dda4c7570015 37 fields · synced May 31, 2026