UDI device identifier
UltraSet CAPD Disposable Disconnect Y-Set 5C4366P
UDI device identifier 00085412030579 · BAXTER INTERNATIONAL INC.
Key facts
| Primary DI | 00085412030579 |
|---|---|
| Brand name | UltraSet CAPD Disposable Disconnect Y-Set |
| Version or model | 5C4366P |
| Catalog number | 5C4366P |
| Company | BAXTER INTERNATIONAL INC. |
| DUNS number | 005146311 |
| Product code | KDJ |
| GMDN term | Peritoneal dialysis system tubing set |
| Premarket submission | K961825 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Oct 7, 2015 |
| Version date | Jul 6, 2018 |
| Description | The UltraSet products are single use devices that are intended for the drainage and infusion of peritoneal dialysis solution. |
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: