UDI device identifier
Calibration Strip (Urisys 1100, cobas u 411) 11379194160
UDI device identifier 00075537180075 · Roche Diagnostics GmbH
Key facts
| Primary DI | 00075537180075 |
|---|---|
| Brand name | Calibration Strip (Urisys 1100, cobas u 411) |
| Version or model | 11379194160 |
| Catalog number | 11379194160 |
| Company | Roche Diagnostics GmbH |
| DUNS number | 315028860 |
| Product code | KHE |
| GMDN term | Multiple-type clinical chemistry analyte profile IVD, calibrator |
| Premarket submission | K033548 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 20, 2016 |
| Version date | Dec 21, 2020 |
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: