UDI device identifier

TRUEbalance TRUEbalance 10 Blood Glucose Test Strips

UDI device identifier 00021292007942 · TRIVIDIA HEALTH, INC.

Key facts

Primary DI 00021292007942
Brand name TRUEbalance
Version or model TRUEbalance 10 Blood Glucose Test Strips
Company TRIVIDIA HEALTH, INC.
DUNS number 151810868
Product code CGA
GMDN term Glucose monitoring system IVD, home-use
Premarket submission K090495
Device class Class II
Single use Yes
Packaged sterile No
Implantable No
Publish date Sep 20, 2016
Version date Nov 1, 2021
Description TRUEbalance 10 Blood Glucose Test Strips

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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