UDI device identifier

ASSURE® Prism Blood Glucose Test Strips 532050

UDI device identifier 00015482532505 · Arkray USA, Inc.

Key facts

Primary DI 00015482532505
Brand name ASSURE® Prism Blood Glucose Test Strips
Version or model 532050
Company Arkray USA, Inc.
DUNS number 008171162
Product code CGA
GMDN term Glucose monitoring system IVD, home-use
Premarket submission K120351
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Sep 23, 2016
Version date Aug 24, 2026
Description Blood Glucose Test Strips, Individually Foiled

At a glance

  • 1–9 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:

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