UDI device identifier
AMIA Automated PD Cycler 5C9320
UDI device identifier 00085412490120 · BAXTER INTERNATIONAL INC.
Key facts
| Primary DI | 00085412490120 |
|---|---|
| Brand name | AMIA Automated PD Cycler |
| Version or model | 5C9320 |
| Catalog number | 5C9320 |
| Company | BAXTER INTERNATIONAL INC. |
| DUNS number | 005146311 |
| Product code | FKX |
| GMDN term | Peritoneal dialysis system |
| Premarket submission | K151525 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Nov 4, 2015 |
| Version date | Jul 21, 2023 |
| Description | Amia Automated PD System is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis |
At a glance
- 10–99 MAUDE reports citing this UDI
- Yes 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: