UDI device identifier
ARK Care® Version 2.5.3.
UDI device identifier 00015482000011 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482000011 |
|---|---|
| Brand name | ARK Care® |
| Version or model | Version 2.5.3. |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | JQP |
| GMDN term | Self-care monitoring/reporting software |
| Premarket submission | K110709 |
| Device class | Class I |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Sep 23, 2016 |
| Version date | Aug 24, 2026 |
| Description | ARK Care is a Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the… |
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: