AccuDrain® External CSF Drainage System SP0219

GUDID 10381780072096

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.

Integra Lifesciences Corporation

Lumbar cerebrospinal fluid drainage kit

• Primary Device ID: 10381780072096
• NIH Device Record Key: 492da2fe-ceb6-4dc8-9634-a24eac2dce4b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuDrain® External CSF Drainage System
• Version Model Number: SP0219
• Catalog Number: SP0219
• Company DUNS: 083171244
• Company Name: Integra Lifesciences Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780072096 [Primary]
HIBCC	M269SP02191 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042825

FDA Product Code

• JXG: Shunt, central nervous system and components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-22
• Device Publish Date: 2015-09-22

On-Brand Devices [AccuDrain® External CSF Drainage System]

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• 10381780072133: ACCUDRAIN NEEDLE SITE The AccuDrain TM External Drainage Systems are designed to externally drai
• 10381780072126: The AccuDrain External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from the v
• 10381780072119: ACCUDRAIN SPECIAL SYSTEM The AccuDrain™ External CSF Drainage System is used to drain cerebros
• 10381780072102: ACCUDRAIN SPECIAL SYSTEM The AccuDrain™ External CSF Drainage System is used to drain cerebros
• 10381780072096: The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from th
• 10381780072089: The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from th
• 10381780072072: The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from th
• 10381780072065: The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from th
• 10381780072058: The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from th
• 10381780072041: The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from th
• 10381780023876: ACCUDRAIN EVD SYSTEM AccuDrain® External CSF Drainage System is used to drain cerebrospinal flu