UDI device identifier
PRISMAFLEX SET 107636US
UDI device identifier 00085412954073 · GAMBRO INDUSTRIES
Key facts
| Primary DI | 00085412954073 |
|---|---|
| Brand name | PRISMAFLEX SET |
| Version or model | 107636US |
| Catalog number | 107636US |
| Company | GAMBRO INDUSTRIES |
| DUNS number | 393020474 |
| Product code | KDI |
| GMDN term | Haemofilter |
| Premarket submission | K212216 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | Yes |
| Implantable | No |
| Publish date | Nov 22, 2022 |
| Version date | Nov 30, 2022 |
| Description | Disposable extracorporeal circuit |
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: