UDI device identifier
CVS Health At Home A1C Test Kit 3059
UDI device identifier 00050428350423 · WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Key facts
| Primary DI | 00050428350423 |
|---|---|
| Brand name | CVS Health At Home A1C Test Kit |
| Version or model | 3059 |
| Catalog number | 3059 |
| Company | WOONSOCKET PRESCRIPTION CENTER, INCORPORATED |
| DUNS number | 062312574 |
| Product code | LCP |
| GMDN term | Glycated haemoglobin (HbA1c) monitoring system IVD, home-use |
| Premarket submission | K090413 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Nov 15, 2016 |
| Version date | Jul 6, 2018 |
| Description | The CVS Health At Home A1C Test Kit provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples. |
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: