UDI device identifier
LOW RECIRCULATION VOLUME APD SET 5C8302C
UDI device identifier 00085412087405 · BAXTER INTERNATIONAL INC.
Key facts
| Primary DI | 00085412087405 |
|---|---|
| Brand name | LOW RECIRCULATION VOLUME APD SET |
| Version or model | 5C8302C |
| Catalog number | 5C8302C |
| Company | BAXTER INTERNATIONAL INC. |
| DUNS number | 005146311 |
| Product code | FKX |
| GMDN term | Peritoneal dialysis system tubing set |
| Premarket submission | K012988 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Sep 24, 2015 |
| Version date | Jul 21, 2023 |
| Description | This Automated PD Set is compatible with Baxter Automated PD systems, Baxter PD Transfer Sets and Effluent Sample Bag. Use of the Clamp for Outlet Port is recommended. Low Recirculation Volume APD Set with Cassette (4-Prong Spike) |
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: