IRRAflow® 1.5 Catheter

Basic Information

• Brand Name: IRRAflow® 1.5 Catheter
• Primary DI: 00868643000425
• Version / Model: ICGS 010
• Catalog Number: ICGS 010
• Company Name: IRRAS USA
• Labeler DUNS: 056999617
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-22
• Public Version: 3
• Public Version Date: 2023-07-14
• Public Version Status: Update
• Public Device Record Key: 84263d6f-d17c-4359-8881-3de4e861b197
• Distribution End Date: 2021-07-07

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: Yes
• MRI Safety: MR Conditional
• 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
GWM	Device, Monitoring, Intracranial Pressure	Neurology	882.1620	2
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	00868643000425	GS1
Package	10868643000422	GS1	Box	10	Not in Commercial Distribution	2021-07-07

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K171880	000

Storage Conditions

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