UDI device identifier
i-STAT 03P75-50
UDI device identifier 00054749003358 · ABBOTT POINT OF CARE INC.
Key facts
| Primary DI | 00054749003358 |
|---|---|
| Brand name | i-STAT |
| Version or model | 03P75-50 |
| Catalog number | 03P75-50 |
| Company | ABBOTT POINT OF CARE INC. |
| DUNS number | 079226216 |
| Product code | CGA |
| GMDN term | Multiple clinical chemistry analyser IVD, point-of-care |
| Premarket submission | K103195 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 9, 2016 |
| Version date | Oct 18, 2023 |
| Description | i-Stat 1 Wireless Analyzer |
At a glance
- 1–9 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: