Duns Number:005146311
Device Description: This device is a double sealing male Luer lock intended for use with the Baxter Locking Ti This device is a double sealing male Luer lock intended for use with the Baxter Locking Titanium Adapter for Peritoneal Dialysis.
Catalog Number
5C4169
Brand Name
Locking Cap for Peritoneal Dialysis Catheter Adapter
Version/Model Number
5C4169
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
8dd3e015-6ec4-429e-bd99-83220edb9779
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 07, 2015
Package DI Number
50085412007439
Quantity per Package
25
Contains DI Package
00085412007434
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 |