UDI device identifier

GLUCOCARD® W Blood Glucose Monitoring System 511100

UDI device identifier 00015482511104 · Arkray USA, Inc.

Key facts

Primary DI 00015482511104
Brand name GLUCOCARD® W Blood Glucose Monitoring System
Version or model 511100
Company Arkray USA, Inc.
DUNS number 008171162
Product code NBW
GMDN term Glucose monitoring system IVD, home-use
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Apr 1, 2019
Version date Aug 24, 2026
Description The GLUCOCARD W Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as the palm. For single-patient use only.

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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