UDI device identifier
Empty Sterile Container 5C4462
UDI device identifier 00085412007670 · BAXTER INTERNATIONAL INC.
Key facts
| Primary DI | 00085412007670 |
|---|---|
| Brand name | Empty Sterile Container |
| Version or model | 5C4462 |
| Catalog number | 5C4462 |
| Company | BAXTER INTERNATIONAL INC. |
| DUNS number | 005146311 |
| Product code | FKX |
| GMDN term | Peritoneal dialysis system tubing set |
| Premarket submission | K833065 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Sep 24, 2015 |
| Version date | Jul 21, 2023 |
| Description | This set is intended for use with a Baxter transfer set for peritoneal dialysis patients requiring a sterile container for drainage. (i.e. CCPD patients doing a daytime exchange or CAPD patients who have disconnected between exchanges). |
At a glance
- 1–9 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: