← Back to catalogue

Drainage Set LiquoGuard US

FDA UDI

Class II (US FDA UDI)

by Möller Medical GmbH

Identity

Trade Name
Drainage Set LiquoGuard US FDA UDI
Generic Name
Cerebrospinal fluid pressure regulation system, peristaltic pump FDA UDI
Device Name
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. FDA UDI
Model / Reference
00003639 FDA UDI
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. FDA UDI

Identifiers

Primary DI / UDI-DI
04260277175931 FDA UDI
510(k) Number
K121248 FDA UDI
FDA Product Code
JXG FDA UDI
GMDN Term
Cerebrospinal fluid pressure regulation system, peristaltic pump FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Cerebrospinal fluid pressure regulation system sensor/tubing setCerebrospinal fluid pressure regulation system, peristaltic pump

Drainage Set LiquoGuard US by Möller Medical GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cerebrospinal fluid pressure regulation system, peristaltic pump.

Cleared under the same submission

K121248 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Möller Medical GmbH

Sources (1)

  • FDA UDI 9fd4e71c-1c99-43b8-a078-139234dae716 35 fields · synced Jun 9, 2026