DEVICE: LiquoGuard (04260277170011)

Device Identifier (DI) Information

LiquoGuard
00002563
In Commercial Distribution

Möller Medical GmbH
04260277170011
GS1

1
320405061 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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).
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.
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FDA Product Code

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Product Code Product Code Name
JXG Shunt, Central Nervous System And Components
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FDA Premarket Submission

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Premarket Submission Number Not Available/Not Released
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Sterilization

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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
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Device Record Status

4b17a2a4-054f-4f9e-8a84-732926e8d097
March 29, 2018
2
October 22, 2015
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Alternative and Additional Identifiers Additional Identifiers

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Unit of Use DI

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Direct Marking (DM)

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Production Identifier(s) in UDI

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Customer Contact

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