UDI device identifier
GLUCOCARD® Shine Level 1 Control Solution 540005
UDI device identifier 00015482540050 · Arkray USA, Inc.
Key facts
| Primary DI | 00015482540050 |
|---|---|
| Brand name | GLUCOCARD® Shine Level 1 Control Solution |
| Version or model | 540005 |
| Company | Arkray USA, Inc. |
| DUNS number | 008171162 |
| Product code | JJX |
| GMDN term | Glucose IVD, control |
| Device class | Class I |
| Single use | No |
| Packaged sterile | No |
| Implantable | No |
| Publish date | Jan 22, 2019 |
| Version date | Aug 24, 2026 |
| Description | GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540050 is used as the… |
At a glance
- None MAUDE reports citing this UDI
- No 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: