Duns Number:531408342
Device Description: The peritoneal catheter is used to drain cerebrospinal fluid from the outlet of the valve The peritoneal catheter is used to drain cerebrospinal fluid from the outlet of the valve unit into the peritoneum. The distal end of the catheter has four staggered rows of 6-mm slits, which are not readily visible. If the distal outlet hole of the catheter becomes obstructed, the slits open for drainage. The slits perform optimally in a saline environment after soaking for 24 hours at 37 degrees Celsius.
Catalog Number
9MD101
Brand Name
Peritoneal Catheter
Version/Model Number
9MD101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 03, 2018
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"
Yes
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
K033698,K861377
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
e78325b6-3aee-4fb2-bb33-1b551561b2a9
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
October 01, 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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |