UDI device identifier
Assure® Platinum BLOOD GLUCOSE TEST STRIPS 500050 500100
UDI device identifier 00015482500504 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482500504 |
|---|---|
| Brand name | Assure® Platinum BLOOD GLUCOSE TEST STRIPS |
| Version or model | 500050 500100 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | CGA |
| GMDN term | Glucose monitoring system IVD, home-use |
| Premarket submission | K092104 |
| Device class | Class II |
| Single use | Yes |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Feb 12, 2017 |
| Version date | Aug 24, 2026 |
| Description | Blood Glucose Test Strips |
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: