UDI device identifier
GLUCOCARD® Shine Blood Glucose Monitoring System 540001
UDI device identifier 00015482540012 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482540012 |
|---|---|
| Brand name | GLUCOCARD® Shine Blood Glucose Monitoring System |
| Version or model | 540001 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | NBW |
| GMDN term | Glucose monitoring system IVD, home-use |
| Premarket submission | K120351 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Apr 19, 2017 |
| Version date | Aug 24, 2026 |
| Description | The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state… |
At a glance
- 1–9 MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 1,000+ 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: