IRRAflow Catheter 2.0+

Basic Information

• Brand Name: IRRAflow Catheter 2.0+
• Primary DI: 00850013266258
• Version / Model: ICAT 030
• Company Name: Irras USA, Inc.
• Labeler DUNS: 056999617
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-07
• Public Version: 1
• Public Version Date: 2025-05-15
• Public Version Status: New
• Public Device Record Key: e7c7ec5a-e4d3-467b-b866-bf52f58599e6

Device Description

IRRAflow Catheter 2.0+ intended for use with the IRRAflow Active Fluid Exchange System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• 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	00850013266258	GS1

Premarket Submissions

Submission Number	Supplement Number
K231664	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 50 Degrees Celsius