DEVICE: AccuDrain® External CSF Drainage System (10381780072140)
Device Identifier (DI) Information
AccuDrain® External CSF Drainage System
SP0238
In Commercial Distribution
SP0238
Integra Lifesciences Corporation
SP0238
In Commercial Distribution
SP0238
Integra Lifesciences Corporation
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, hydrocephalus hunt infections, intracranial hemorrhage and pre and/or post operative monitoring. Common features of the system include a closed sterile fluid path, calibrated 75mL graduated burette, 700mL drainage bag, anti-microbial hydrophobic vent, two needless 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 of laser device can be attached. The transparent graduated burette provides visualization of the flow and clarify of the CSF, and allows for volumetric readings to be made prior to fluid entering the drainage bag.
Device Characteristics
MR Safe | |
No | |
Yes | |
Yes | |
Yes | |
No | |
Yes | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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) 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.
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Active | false |
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) 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JXG | Shunt, central nervous system and components |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K042825 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store at room temperature. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
169f2d7c-f9cb-4ce0-ac0f-f78ba5f12252
December 23, 2024
6
September 22, 2015
December 23, 2024
6
September 22, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
HIBCC | M269SP02381 |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)654-2873
custsvcnj@integralife.com
custsvcnj@integralife.com