Duns Number:005083209
Device Description: This adapter consists of a spike connector, approx. 10.15 cm (4 inch) long, 3.81 mm (0.150 This adapter consists of a spike connector, approx. 10.15 cm (4 inch) long, 3.81 mm (0.150 inch) ID tubing and a flanged Easy-Lock Connector. This device is indicated for the personal cycler peritoneal dialysis system used for automatic control of dialysate solution exchanges in the treatment of renal failure patients undergoing peritoneal dialysis.
Catalog Number
5C4136
Brand Name
Easy-Lock
Version/Model Number
5C4136
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"
Yes
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
K923065,K923065
Product Code
FKX
Product Code Name
System, peritoneal, automatic delivery
Public Device Record Key
4144d8ee-71b5-471d-b365-be4eccda5158
Public Version Date
November 30, 2020
Public Version Number
2
DI Record Publish Date
November 14, 2018
Package DI Number
50085412050824
Quantity per Package
12
Contains DI Package
00085412050829
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 |