Duns Number:005146311
Device Description: This set consists of a female locking connector/on-0ff clamp assembly, tubing and double s This set consists of a female locking connector/on-0ff clamp assembly, tubing and double sealing male Luer lock connector. This set it to be used with Baxter Locking Titanium Adapter for Peritoneal Dialysis Catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture.
Catalog Number
5C4483
Brand Name
MiniCap
Version/Model Number
5C4483
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"
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
KDJ
Product Code Name
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Public Device Record Key
635c2a8d-6144-43f1-b613-72a5b4b96024
Public Version Date
October 19, 2022
Public Version Number
4
DI Record Publish Date
December 21, 2017
Package DI Number
50085412007743
Quantity per Package
6
Contains DI Package
00085412007748
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 |