Duns Number:005146311
Device Description: This set is designed for infusion of peritoneal dialysis solution. This set consists of a This set is designed for infusion of peritoneal dialysis solution. This set consists of a white luer lock connector (with blue pull ring cap) which is intended to connect to a supply line of an APD Set with Cassette and 5 blue luer lock connectors (with clear pull ring caps) which are intended to connect to solution bags (with Luers). Manifold Set 5-Prong
Catalog Number
L5C4446
Brand Name
Manifold Set
Version/Model Number
L5C4446
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
K791899,K791899
Product Code
KDJ
Product Code Name
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
Public Device Record Key
17eea6fa-208a-4d1b-b37c-8892cd38268e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2015
Package DI Number
50085412090097
Quantity per Package
15
Contains DI Package
00085412090092
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 |