Duns Number:038000253
Device Description: 15F X 31CM I-SERIES STRAIGHT PERITONEAL DIALYSIS CATHETER W/1CUFF(CATHETER ONLY)
Catalog Number
-
Brand Name
I-SERIES PD Catheter
Version/Model Number
MC20IS31SC
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"
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
5a4b3f67-9840-45dd-b959-1e9d91b9a4d4
Public Version Date
October 15, 2018
Public Version Number
4
DI Record Publish Date
October 23, 2015
Package DI Number
50884908092320
Quantity per Package
5
Contains DI Package
00884908092325
Package Discontinue Date
-
Package Status
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 |