UDI device identifier
Assure® Titanium Blood Glucose Test Strips 600100
UDI device identifier 00015482601003 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482601003 |
|---|---|
| Brand name | Assure® Titanium Blood Glucose Test Strips |
| Version or model | 600100 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | PZI |
| GMDN term | Glucose monitoring system IVD, point-of-care |
| Premarket submission | K200788 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 15, 2025 |
| Version date | Aug 24, 2026 |
| Description | The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered Assure Titanium Blood Glucose meter, disposable single-use Assure Titanium Blood Glucose Test Strips, Assure Control-Control Solutions (Level 1, 2 and Level 3), Quick Reference Guide and User Manual. Assure Titanium… |
At a glance
- None MAUDE reports citing this UDI
- Yes Linked premarket submission
- No EUDAMED counterpart found
- 10–99 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: