Duns Number:320405061
Device Description: The LiquoGuard 7 tube set consists of a tubing, stop cocks with luer locks, a drainage bag The LiquoGuard 7 tube set consists of a tubing, stop cocks with luer locks, a drainage bag with a reflux valve, adapters to ensure correct insertion into the pump, and a pressure sensor housing with two pressure transducers, a cable for connection to the pump and a sticker to attach the sensor housing to the patient's skin. The tube set is only for use with the LiquoGuard 7.
Catalog Number
-
Brand Name
Drainage Set LiquoGuard 7
Version/Model Number
00003501 2411
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
K150898,K150898,K150898
Product Code
JXG
Product Code Name
Shunt, Central Nervous System And Components
Public Device Record Key
a82c9480-9959-4544-b78a-436ed9a7bec8
Public Version Date
January 10, 2022
Public Version Number
2
DI Record Publish Date
October 31, 2018
Package DI Number
04260277176167
Quantity per Package
60
Contains DI Package
04260277176150
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |