UDI device identifier

ARK Care® Advance Diabetes Management System Ver 2.0.

UDI device identifier 00015482000028 · Arkray USA, Inc.

Key facts

Primary DI 00015482000028
Brand name ARK Care® Advance Diabetes Management System
Version or model Ver 2.0.
Company Arkray USA, Inc.
DUNS number 008171162
Product code JQP
GMDN term Self-care monitoring/reporting software
Device class Class I
Single use No
Packaged sterile No
Implantable No
Publish date Mar 12, 2020
Version date Aug 24, 2026
Description ARK Care Advance 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…

At a glance

  • None MAUDE reports citing this UDI
  • No 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:

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