ARES™

Basic Information

• Brand Name: ARES™
• Primary DI: 20643169288885
• Version / Model: 95001
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Labeler DUNS: 089055867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-01
• Public Version: 3
• Public Version Date: 2021-12-06
• Public Version Status: Update
• Public Device Record Key: 0c9a9372-98db-4e05-ae36-067cf4bcb20b

Device Description

CATHETER 95001 KIT ANTIMICROBIAL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
61376	Intracerebral infusion/drainage catheter, long-term	A sterile, flexible tube intended to be surgically inserted through the skull for long-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 is typically used for measurement of intracranial pressure (ICP) and as part of a shunt system. 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, catheter holder); it does not include a sensor. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20643169288885	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K110560	000

Device Sizes

Type	Value	Unit	Text
Length	120.0	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 27 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight