UDI device identifier
i-STAT 02R60-05
UDI device identifier 00054749005611 · ABBOTT POINT OF CARE INC.
Key facts
| Primary DI | 00054749005611 |
|---|---|
| Brand name | i-STAT |
| Version or model | 02R60-05 |
| Company | ABBOTT POINT OF CARE INC. |
| DUNS number | 079226216 |
| Product code | QAT |
| GMDN term | Multiple clinical chemistry analyser IVD, point-of-care |
| Premarket submission | K201778 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Oct 12, 2021 |
| Version date | Oct 18, 2023 |
| Description | I-STAT ALINITY SYSTEM KIT |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1–9 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: