Drainage Set LiquoGuard US
- Primary DI
- 04260277175931
- Brand
- Drainage Set LiquoGuard US
- Company
- Möller Medical GmbH
- Model
- 00003639
- 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
- MR Conditional
- Rx
- true
- Sterile
- true
- Single use
- 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 |
|---|---|---|---|---|
| 04260277175948 | Package | GS1 | 10 | In Commercial Distribution |
| 04260277175955 | Package | GS1 | 60 | In Commercial Distribution |
| 04260277175931 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 04260277175948 | 04260277175948 | 4260277175948 |
| 04260277175955 | 04260277175955 | 4260277175955 |
| 04260277175931 | 04260277175931 | 4260277175931 |
GMDN Terms#
| Term | Definition |
|---|---|
| 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. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 14 Degrees Fahrenheit | 122 Degrees Fahrenheit |
Regulatory Flags#
- DUNS number
- 320405061
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
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