AccuDrain® External CSF Drainage System SP0222

GUDID 10381780072102

ACCUDRAIN SPECIAL SYSTEM 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, ubarachnoid 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, 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

Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit Ventricular cerebrospinal fluid drainage catheterization kit
Primary Device ID10381780072102
NIH Device Record Key311acff9-18c5-4847-88d0-94597e34fc97
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuDrain® External CSF Drainage System
Version Model NumberSP0222
Catalog NumberSP0222
Company DUNS083171244
Company NameIntegra Lifesciences Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com
Phone+1(800)654-2873
Emailcustsvcnj@integralife.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature.

Device Identifiers

Device Issuing AgencyDevice ID
GS110381780072102 [Primary]
HIBCCM269SP02221 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JXGShunt, central nervous system and components

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-09-22
Device Publish Date2015-09-22

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

10381780072140The AccuDrain External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from the v
10381780072133ACCUDRAIN NEEDLE SITE The AccuDrain TM External Drainage Systems are designed to externally drai
10381780072126The AccuDrain External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from the v
10381780072119ACCUDRAIN SPECIAL SYSTEM The AccuDrain™ External CSF Drainage System is used to drain cerebros
10381780072102ACCUDRAIN SPECIAL SYSTEM The AccuDrain™ External CSF Drainage System is used to drain cerebros
10381780072096The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from th
10381780072089The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from th
10381780072072The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from th
10381780072065The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from th
10381780072058The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from th
10381780072041The AccuDrain™ External CSF Drainage System is used to drain cerebrospinal fluid (CSF) from th
10381780023876ACCUDRAIN EVD SYSTEM AccuDrain® External CSF Drainage System is used to drain cerebrospinal flu

Trademark Results [AccuDrain]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCUDRAIN
ACCUDRAIN
77148604 3434290 Live/Registered
Integra LifeSciences Corporation
2007-04-04

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.