UDI device identifier

OptiumEZ 71065

UDI device identifier 00093815710653 · ABBOTT DIABETES CARE INC

Key facts

Primary DI 00093815710653
Brand name OptiumEZ
Version or model 71065
Catalog number 71065
Company ABBOTT DIABETES CARE INC
DUNS number 966390890
Product code NBW
GMDN term Multiple clinical chemistry analyte monitoring system IVD, home-use
Premarket submission K081975
Device class 1 | 2
Single use Yes
Packaged sterile No
Implantable No
Publish date Aug 12, 2016
Version date Oct 18, 2023
Description Optium EZ Blood Glucose Monitoring System

At a glance

  • 10–99 MAUDE reports citing this UDI
  • Yes 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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