Duns Number:005146311
Device Description: This adapter is a double sealing female Luer lock adapter with a 2-piece, combination comp This adapter is a double sealing female Luer lock adapter with a 2-piece, combination compression fit/barbed catheter connector. The adapter is used to connect the PD catheter to a solution transfer set with locking connector.
Catalog Number
5C4129
Brand Name
Locking Titanium Adapter for Peritoneal Dialysis Catheter
Version/Model Number
5C4129
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"
-
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
KDJ
Product Code Name
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Public Device Record Key
d45e3ef9-955b-4a4a-8801-6d4e7a8bcaa7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 07, 2015
Package DI Number
50085412007408
Quantity per Package
5
Contains DI Package
00085412007403
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |