IRRAflow Catheter 2.0+

GUDID 00850013266258

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

Irras USA, Inc.

Intracerebral infusion/drainage catheter, short-term

• Primary Device ID: 00850013266258
• NIH Device Record Key: e7c7ec5a-e4d3-467b-b866-bf52f58599e6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IRRAflow Catheter 2.0+
• Version Model Number: ICAT 030
• Company DUNS: 056999617
• Company Name: Irras USA, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850013266258 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231664

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-15
• Device Publish Date: 2025-05-07

Devices Manufactured by Irras USA, Inc.

• 10850013266279 - IRRAflow Cranial Access Bolt: 2025-08-01 The IRRAflow Cranial Access Bolt is a single use, single-lumen bolt intended for use with the IRRAflow Dual Lumen Catheter to se
• 00850013266258 - IRRAflow Catheter 2.0+: 2025-05-15IRRAflow Catheter 2.0+ intended for use with the IRRAflow Active Fluid Exchange System
• 00850013266258 - IRRAflow Catheter 2.0+: 2025-05-15 IRRAflow Catheter 2.0+ intended for use with the IRRAflow Active Fluid Exchange System
• 10868643000460 - IRRAflow Laser Leveler Package: 2024-06-18