UDI device identifier
Revaclear Revaclear 400
UDI device identifier 00085412908427 · Baxter Healthcare SA
Key facts
| Primary DI | 00085412908427 |
|---|---|
| Brand name | Revaclear |
| Version or model | Revaclear 400 |
| Catalog number | 114746A |
| Company | Baxter Healthcare SA |
| DUNS number | 481009905 |
| Product code | KDI |
| GMDN term | Hollow-fibre haemodialysis dialyser, single-use |
| Premarket submission | K213639 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Apr 12, 2024 |
| Version date | Apr 22, 2024 |
| Description | Revaclear 400 dialyzer is indicated for the treatment of chronic or acute renal failure. |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 100–999 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: