Duns Number:038000253
Device Description: 15F X 18CM STRAIGHT PERITONEAL DIALYSIS CATHETER SET W/1 CUFF
Catalog Number
-
Brand Name
MEDCOMP PERITONEAL DIALYSIS CATHETERMEDCOMP PERITONEAL DIALYSIS CATHETER
Version/Model Number
MPD-118
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
878ef174-d164-4368-9764-3f03714408e4
Public Version Date
August 22, 2018
Public Version Number
4
DI Record Publish Date
January 10, 2017
Package DI Number
50884908030797
Quantity per Package
5
Contains DI Package
00884908030792
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 |