Duns Number:005083209
Device Description: This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodi This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.
Catalog Number
5C4466P
Brand Name
MINICAP WITH POVIDONE-IODINE SOLUTION
Version/Model Number
5C4466P
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
d6c3779b-8d07-48c9-ac63-4369f68ce95b
Public Version Date
November 23, 2020
Public Version Number
4
DI Record Publish Date
October 07, 2015
Package DI Number
50085412007699
Quantity per Package
60
Contains DI Package
00085412007694
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |