UDI device identifier

LEADER 5465349

UDI device identifier 00096295135855 · Cardinal Health 110, Inc.

Key facts

Primary DI 00096295135855
Brand name LEADER
Version or model 5465349
Catalog number 5465349
Company Cardinal Health 110, Inc.
DUNS number 063997360
Product code JMT
GMDN term Urine nitrite IVD, kit, rapid colorimetric, clinical
Device class Class I
Single use Yes
Packaged sterile No
Implantable No
Publish date Apr 18, 2019
Version date Dec 18, 2023
Description Leader Urinary Tract Infection Home Test, 3 COUNT

At a glance

  • None MAUDE reports citing this UDI
  • No Linked premarket submission
  • No EUDAMED counterpart found
  • 10–99 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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