Duns Number:038000253
Device Description: 15F X 57.5CM COILED PERITONEAL DIALYSIS CATHETER SET W/2 CUFFS
Catalog Number
-
Brand Name
Coiled PD Catheter
Version/Model Number
MPD-257
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 28, 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
-
Product Code
FJS
Product Code Name
CATHETER, PERITONEAL, LONG-TERM INDWELLING
Public Device Record Key
1034d205-a879-4f6d-9812-9a315d9e9e52
Public Version Date
August 17, 2018
Public Version Number
4
DI Record Publish Date
November 17, 2015
Package DI Number
50884908030872
Quantity per Package
5
Contains DI Package
00884908030877
Package Discontinue Date
June 28, 2018
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 |