Duns Number:005146311
Device Description: The UltraSet products are single use devices that are intended for the drainage and infusi The UltraSet products are single use devices that are intended for the drainage and infusion of peritoneal dialysis solution.
Catalog Number
L5C4366
Brand Name
UltraSet CAPD Disposable Disconnect Y-Set
Version/Model Number
L5C4366
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
K961825,K961825
Product Code
KDJ
Product Code Name
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Public Device Record Key
8a970f32-74bb-4f9b-8818-194e999d3449
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 07, 2015
Package DI Number
50085412090080
Quantity per Package
30
Contains DI Package
00085412090085
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 |