UDI device identifier
AquaFlexFlow UF 500 Plus 114156
UDI device identifier 10853072007111 · Nuwellis Inc.
Key facts
| Primary DI | 10853072007111 |
|---|---|
| Brand name | AquaFlexFlow UF 500 Plus |
| Version or model | 114156 |
| Catalog number | 114156 |
| Company | Nuwellis Inc. |
| DUNS number | 790580182 |
| Product code | KDI |
| GMDN term | Haemofilter |
| Premarket submission | K192756 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Mar 3, 2020 |
| Version date | Mar 16, 2026 |
| Description | For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is… |
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: