LiquoGuard

Primary DI
04260277170011
Brand
LiquoGuard
Company
Möller Medical GmbH
Model
00002563
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.
Published
2015-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JXGShunt, Central Nervous System And Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXGShunt, Central Nervous System And ComponentsNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121248000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121248000LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTACMoller Medical GmbH2013-12-13JXG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260277170011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260277170011042602771700114260277170011

GMDN Terms#

Term, Definition table
TermDefinition
Cerebrospinal fluid pressure regulation system control unit/pumpA 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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
320405061
Device count
1
Serial number
true
Manufacturing date on label
true

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