Duns Number:320405061
Device Description: The LiquoGuard 7 CSF Drainage System consists of a pump and a corresponding disposable dra 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 thissystem 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 andoperates the peristaltic pump of LiquoGuard 7 whenever the current patient’s CSF pressure is higher than a preselected target pressure. Thus the LiquoGuard 7 combinesCSF drainage and intracranial pressure (ICP) monitoring like the predicate device, the LiquoGuard CSF System, with integrated alarm and documentation/data loggingfunctions, improving safety, simplifying the handling and enhancing patient’s mobility.
Catalog Number
-
Brand Name
LiquoGuard 7
Version/Model Number
00003500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150898
Product Code
JXG
Product Code Name
Shunt, Central Nervous System And Components
Public Device Record Key
5fc6bc80-5102-45df-a032-6815a207ab53
Public Version Date
January 10, 2022
Public Version Number
2
DI Record Publish Date
October 31, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 398 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |