Duns Number:005146311
Device Description: This device is a plastic disconnect cap for Automated Peritoneal Dialysis (APD) containing This device is a plastic disconnect cap for Automated Peritoneal Dialysis (APD) containing povidone-iodine.
Catalog Number
5C4456
Brand Name
FlexiCap Disconnect Cap with Povidone-Iodine Solution
Version/Model Number
5C4456
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
de85ade5-d29d-4a20-9209-0827c9f8d51c
Public Version Date
August 26, 2022
Public Version Number
3
DI Record Publish Date
October 07, 2015
Package DI Number
50085412349140
Quantity per Package
30
Contains DI Package
00085412349145
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 |