Duns Number:320405061
Device Description: The LiquoGuard CSF system is indicated for the external drainage of cerebrospinal fluid (C 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 lumbarsubarachnoid 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 systemn 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.
Catalog Number
-
Brand Name
Drainage Set LiquoGuard US
Version/Model Number
00003640
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
Yes
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
K121248,K121248,K121248
Product Code
JXG
Product Code Name
Shunt, Central Nervous System And Components
Public Device Record Key
7a06b2cd-248c-437f-966c-d6bb6ba019d8
Public Version Date
January 10, 2022
Public Version Number
3
DI Record Publish Date
October 22, 2015
Package DI Number
04260277175986
Quantity per Package
60
Contains DI Package
04260277175979
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| 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 |