Duns Number:038000253
Device Description: 15F X 64CM X-SERIES15F X 64CM X- PERITONEAL DIALYSISPERITONEAL DI (CATHETER ONLY)(CATHETER 15F X 64CM X-SERIES15F X 64CM X- PERITONEAL DIALYSISPERITONEAL DI (CATHETER ONLY)(CATHETER ONLY)
Catalog Number
DMC20XC
Brand Name
"X" SERIES PD CATHETER"X" SERIES PD CATHETER
Version/Model Number
DMC20XC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
80458afd-99df-40cb-88d7-844e8c572f21
Public Version Date
June 21, 2019
Public Version Number
1
DI Record Publish Date
June 13, 2019
Package DI Number
50884908143022
Quantity per Package
5
Contains DI Package
00884908143027
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 |