AccessGUDID - DEVICE: AccuDrain® External CSF Drainage System (10381780072041)

GUDID

Device Identifier (DI) Information

Brand Name: AccuDrain® External CSF Drainage System
Version or Model: SP0213
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SP0213
Company Name: Integra Lifesciences Corporation

Primary DI Number: 10381780072041
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083171244 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false
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.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store at room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e87cd44d-2221-4ead-801d-dda4c7570015
Public Version Date: December 23, 2024
Public Version Number: 6
DI Record Publish Date: September 22, 2015