Duns Number:083171244
Device Description: POLE MOUNT, PRESS. MONIT. SYS.The External CSF Drainage Systems provide a sterile fluid pa POLE MOUNT, PRESS. MONIT. SYS.The External CSF Drainage Systems provide a sterile fluid path resistant to microbial particles. The systems are used to drain cerebrospinal fluid (CSF) from the ventricles of the brain or the lumbar subarachnoid space to a drainage bag. System components facilitate CSF drainage, fluid injection, CSF sampling and intracranial pressure monitoring. Common features include a calibrated 50 ml graduated burette, 700 ml drainage bag, anti-microbial hydrophobic vent, needleless sampling/aspiration sites and pressure monitoring green stribed tubing.
Catalog Number
INS8601
Brand Name
Hermetic™ External CSF Drainage System
Version/Model Number
INS8601
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
K972994
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
0dbf252d-b343-4f58-8fab-87de045501aa
Public Version Date
December 15, 2020
Public Version Number
5
DI Record Publish Date
September 22, 2015
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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |