Duns Number:005146311
Device Description: The HomeChoice PRO Automated Personal Cycler is intended for automatic control of dialysat The HomeChoice PRO Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.
Catalog Number
5C8310R
Brand Name
HomeChoice PRO APD System
Version/Model Number
5C8310R
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
-
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
K102936
Product Code
FKX
Product Code Name
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Public Device Record Key
69448221-03b9-4a10-8438-8a2ca8693f15
Public Version Date
October 11, 2022
Public Version Number
4
DI Record Publish Date
October 23, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |