LiquoGuard

Basic Information

• Brand Name: LiquoGuard
• Primary DI: 04260277170011
• Version / Model: 00002563
• Company Name: Möller Medical GmbH
• Labeler DUNS: 320405061
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-22
• Public Version: 3
• Public Version Date: 2022-01-10
• Public Version Status: Update
• Public Device Record Key: 4b17a2a4-054f-4f9e-8a84-732926e8d097

Device Description

The LiquoGuard CSF system is indicated for the external drainage of cerebrospinal fluid (CSF). It connects to any drainage catheter (not part of the product) which is usually inserted by the doctor into the lateral or third ventricle of the brain or lumbar subarachnoid space in selected patients to reduce intracranial pressure. The LiquoGuard CSF system controls CSF pressure using pressure sensors and a pump, thus taking the role of the conventional CSF dripping chamber and collection bag (predicate devices). The LiquoGuard CSF system also monitors intracranial pressure up to 75 mmHg and cerebrospinal fluid flow during CSF drainage, and provides many alarm functions not offered by the passive dripping chamber systems.

Device Characteristics

• Single Use: No
• 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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
59959	Cerebrospinal fluid pressure regulation system control unit/pump	A mains electricity (AC-powered) device, with a rechargeable battery, that is a component of a cerebrospinal fluid pressure regulation system designed to monitor/display cerebrospinal fluid (CSF) pressure, and to aspirate CSF at a rate regulated by CSF pressure, using a peristaltic pump. It is a software-controlled, electronic unit that is connected proximally to a disposable pressure sensor/tubing set and distally to a disposable collection set. It typically has a screen and controls to act as a user interface, and has alarms to signal when pressure measurements indicate possible complications (e.g., catheter occlusion, collapsed ventricle).	No	Active
59958	Cerebrospinal fluid pressure regulation system, peristaltic pump	An assembly of devices designed to simultaneously monitor cerebrospinal fluid (CSF) pressure and aspirate CSF at a rate regulated by the desired intracranial or in-tube CSF pressure. It is connected to a dedicated CSF access device (e.g., catheter, needle) inserted into the cerebral ventricles or subarachnoid (intrathecal) space of the spinal column. It consists of a mains electricity (AC-powered) control unit (and rechargeable battery) with a peristaltic pump and user interface; a disposable tubing set with integrated pressure sensor; and a disposable collection set. It is typically used in trauma, normal pressure hydrocephalus (NPH) diagnostics, and during major vascular surgery.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260277170011	GS1

Premarket Submissions

Submission Number	Supplement Number
K121248	000