CerebroFlo EVD Catheter Set

Basic Information

• Brand Name: CerebroFlo EVD Catheter Set
• Primary DI: 10866614000105
• Version / Model: 37.550.501
• Catalog Number: 37.550.501
• Company Name: ARKIS BIOSCIENCES INC.
• Labeler DUNS: 078846878
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-24
• Public Version: 5
• Public Version Date: 2022-07-06
• Public Version Status: Update
• Public Device Record Key: b3a38145-55be-4f7a-a6b1-f4cb46fdd2e4

Device Description

The CerebroFlo EVD Catheter is a polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through the drainage holes near the catheter's tip. The catheter is barium-sulfate impregnated to provide radiopacity. The CerebroFlo EVD Catheter is provided with a Stylette, Trocar, Barbed Leur Connector, Male Leur Cap, and a suture clip.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXG	Shunt, Central Nervous System And Components	Neurology	882.5550	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61399	Intracerebral infusion/drainage catheter, short-term	A flexible tube intended to be surgically inserted through the skull for short-term (= 30 days) subdural access to the brain (e.g., cerebral ventricles, cystic tumours) for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents); it may also be intended for measurement of intracranial pressure (ICP). It may include an attached port/reservoir at its proximal end that is placed subcutaneously to facilitate material infusion/collection, and/or accessory devices intended to facilitate catheter introduction and/or stabilization (e.g., stylet, bolts, drills, catheter holder); it does not include a sensor. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10866614000105	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K170599	000

Device Sizes

Type	Value	Unit	Text
Length	35	Centimeter
Outer Diameter	3.3	Millimeter