Duns Number:832696038
Device Description: PeritX Peritoneal Catheter and Starter Kit, For Peritoneal Placement Only and For Patient PeritX Peritoneal Catheter and Starter Kit, For Peritoneal Placement Only and For Patient Home Use
Catalog Number
50-9900C
Brand Name
PeritX
Version/Model Number
50-9900C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
-
Product Code
PNG
Product Code Name
Peritoneal, drainage catheter for refractory ascites, long-term indwelling
Public Device Record Key
09d28a3b-90bd-46c6-b88f-96cb60804537
Public Version Date
March 17, 2021
Public Version Number
1
DI Record Publish Date
March 09, 2021
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |