UDI device identifier
GLUCOCARD® EXPRESSION Blood Glucose Monitoring System 570001
UDI device identifier 00015482570101 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482570101 |
|---|---|
| Brand name | GLUCOCARD® EXPRESSION Blood Glucose Monitoring System |
| Version or model | 570001 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | NBW |
| GMDN term | Glucose monitoring system IVD, home-use |
| Premarket submission | K113098 |
| Device class | Class II |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 23, 2016 |
| Version date | Aug 24, 2026 |
| Description | Portable Blood Glucose Meter |
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: