UDI device identifier

GLUCOCARD® Shine Level 2 Control Solution 540007

UDI device identifier 00015482540074 · Arkray USA, Inc.

Key facts

Primary DI 00015482540074
Brand name GLUCOCARD® Shine Level 2 Control Solution
Version or model 540007
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 2 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# 015482540074 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:

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