Camino®

Basic Information

• Brand Name: Camino®
• Primary DI: 10381780250395
• Version / Model: VTUN
• Company Name: INTEGRA NEUROSCIENCES IMPLANT (FRANCE)
• Labeler DUNS: 531408342
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-04
• Public Version: 7
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: cc9de073-5a5d-43df-816b-7159ec317de2
• Distribution End Date: 2019-02-28

Device Description

The Camino Flex Ventricular Intracranial Pressure Monitoring Kit is indicated when direct and continuous intraventricular intracranial pressure monitoring and cerebrospinal fluid drainage are required. The catheter is embedded with a strain gauge pressure transducer.The system is designed for no more than five days of continuous monitoring.

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: Yes
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
61398	Intracerebral sensor catheter, short-term	A flexible tube with a sensor at the distal end intended to be surgically inserted through the skull for short-term (= 30 days) access to the ventricular and/or parenchymal areas of the brain to measure intracranial parameters [e.g., intracranial pressure (ICP), temperature, partial pressure of oxygen (pO2)]; it may in addition be intended for cerebrospinal fluid (CSF) drainage and/or infusion of materials (e.g., chemotherapeutic agents, radioisotopes). It may include accessory devices intended to facilitate catheter introduction, stabilization, and/or fluid collection/infusion (e.g., stylet, bolts, drills, drainage/infusion port/reservoir). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M272VTUN1	HIBCC
Primary	10381780250395	GS1
Previous	10381780041443	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K133754	000