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 |
|---|---|
| JXG | Shunt, Central Nervous System And Components |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | Neurology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K121248 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 04260277170011 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04260277170011 | 04260277170011 | 4260277170011 |
GMDN Terms#
| Term | 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). |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 320405061
- Device count
- 1
- Serial number
- true
- Manufacturing date on label
- true
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|---|---|---|---|---|
| 04260632793640 | TLA Tubing Liposat Pro plus | 00003997 | 2026-02-27 | |
| 04260632794043 | TLA Tubing Liposat Pro plus | 00003997 | 2026-02-27 | |
| 04260632792339 | TLA Tubing Liposat Pro plus | 00003997 | 2020-01-21 | |
| 04260277172831 | Breast localisation needle | BLM-1110-20-0030 | 2018-08-17 | |
| 04260277172848 | Breast localisation needle | BLM-1110-20-0050 | 2018-08-17 | |
| 04260277172862 | Breast localisation needle | BLM-1110-20-0100 | 2018-12-10 | |
| 04260632791622 | Basket Cannula 2.0 | ASC-R520-30-0250 | 2019-05-09 | |
| 04260632791639 | Basket Cannula 2.0 | ASC-R520-30-0350 | 2019-05-09 | |
| 04260632791646 | Basket Cannula 2.0 | ASC-R520-40-0250 | 2019-05-09 | |
| 04260632791660 | Basket Cannula 2.0 | ASC-R520-50-0250 | 2019-05-09 | |
| 04260632791677 | Basket Cannula 2.0 | ASC-R520-50-0350 | 2019-05-09 | |
| 04260632791684 | Basket Cannula 2.0 | ASC-R521-30-0250 | 2019-05-09 | |
| 04260632791691 | Basket Cannula 2.0 | ASC-R521-30-0350 | 2019-05-09 | |
| 04260632791707 | Basket Cannula 2.0 | ASC-R521-40-0250 | 2019-05-09 | |
| 04260632791721 | Basket Cannula 2.0 | ASC-R521-50-0250 | 2019-05-09 | |
| 04260632790151 | Basket Cannula 2.0 | ASC-S520-40-0350 | 2019-05-06 | |
| 04260632790168 | Basket Cannula 2.0 | ASC-S520-50-0250 | 2019-05-06 | |
| 04260632790175 | Basket Cannula 2.0 | ASC-S520-50-0350 | 2019-05-06 | |
| 04260632790182 | Basket Cannula 2.0 | ASC-S521-30-0250 | 2019-05-06 | |
| 04260632790205 | Basket Cannula 2.0 | ASC-S521-40-0250 | 2019-05-06 |
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