LiquoGuard 7
Basic Information
- Brand Name
- LiquoGuard 7
- Primary DI
- 04260277175788
- Version / Model
- 00003500
- Company Name
- Möller Medical GmbH
- Labeler DUNS
- 320405061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-31
- Public Version
- 2
- Public Version Date
- 2022-01-10
- Public Version Status
- Update
- Public Device Record Key
- 5fc6bc80-5102-45df-a032-6815a207ab53
Device Description
The LiquoGuard 7 CSF Drainage System consists of a pump and a corresponding disposable drainage tube set, including two pressure sensors. The dynamic range of this system is from -75 mmHg to +100 mmHg. The drainage tube set is inserted into the pump, connected to the intrathecal drainage catheter (not part of the product) via a 3- way stopcock and the LiquoGuard 7 device via cable connector. The device continuously measures the pressure of CSF due to the fluid column inside the tube and operates the peristaltic pump of LiquoGuard 7 whenever the current patient’s CSF pressure is higher than a preselected target pressure. Thus the LiquoGuard 7 combines CSF drainage and intracranial pressure (ICP) monitoring like the predicate device, the LiquoGuard CSF System, with integrated alarm and documentation/data logging functions, improving safety, simplifying the handling and enhancing patient’s mobility.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | Neurology | 882.5550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59959 | 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260277175788 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150898 | 000 |
Storage Conditions
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 14 – 122 Degrees Fahrenheit
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry