UDI device identifier
Assure® Platinum 502030
UDI device identifier 00015482502300 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482502300 |
|---|---|
| Brand name | Assure® Platinum |
| Version or model | 502030 |
| 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 | Nov 25, 2019 |
| Version date | Aug 24, 2026 |
| Description | Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (in vitro diognostic use). They are indicated for use at home (over… |
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: