UDI device identifier
PRISMAFLEX SET HF1400
UDI device identifier 07332414069315 · GAMBRO INDUSTRIES
Key facts
| Primary DI | 07332414069315 |
|---|---|
| Brand name | PRISMAFLEX SET |
| Version or model | HF1400 |
| Catalog number | 107142 |
| Company | GAMBRO INDUSTRIES |
| DUNS number | 393020474 |
| Product code | KDI |
| GMDN term | Haemofilter |
| Premarket submission | K042938 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Oct 5, 2015 |
| Version date | Aug 10, 2023 |
| Description | The Prismaflex HF1400 set is indicated for use only with the PrismaFlex system or with the PrisMax system (in countries where PrisMax is cleared or registered) in providing continuous fluid management and renal replacement therapies. The system is intended for patients who have acute renal failure… |
At a glance
- 10–99 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: