UDI device identifier
HomeChoice PRO APD System 5C8310R
UDI device identifier 00085412026350 · BAXTER INTERNATIONAL INC.
Key facts
| Primary DI | 00085412026350 |
|---|---|
| Brand name | HomeChoice PRO APD System |
| Version or model | 5C8310R |
| Catalog number | 5C8310R |
| Company | BAXTER INTERNATIONAL INC. |
| DUNS number | 005146311 |
| Product code | FKX |
| GMDN term | Peritoneal dialysis system |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Oct 23, 2015 |
| Version date | Jun 16, 2025 |
| Description | 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. |
At a glance
- None MAUDE reports citing this UDI
- No Linked premarket submission
- No EUDAMED counterpart found
- 10–99 GUDID devices with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About UDI device identifiers (GUDID)
The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.
Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date: