Duns Number:038000253
Device Description: 10.5F X 37CM STRAIGHT PERITONEAL DIALYSIS CATHETER SET W/1 CUFF
Catalog Number
-
Brand Name
Peritoneal Catheter
Version/Model Number
MPD-137S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 10, 2019
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"
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
FJS
Product Code Name
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Public Device Record Key
8684f0c4-1d2f-4f93-9a63-900c49d3eca1
Public Version Date
October 17, 2019
Public Version Number
5
DI Record Publish Date
March 30, 2016
Package DI Number
50884908030803
Quantity per Package
5
Contains DI Package
00884908030808
Package Discontinue Date
October 10, 2019
Package Status
Not in Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |