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
EZPC4466
Brand Name
MiniCap
Version/Model Number
EZPC4466
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
2143c05f-60fc-4376-a334-a93757dded14
Public Version Date
July 30, 2019
Public Version Number
1
DI Record Publish Date
July 22, 2019
Package DI Number
50085412656026
Quantity per Package
60
Contains DI Package
00085412656021
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 |