UDI device identifier

LEADER 5915004

UDI device identifier 00096295143850 · Cardinal Health 110, Inc.

Key facts

Primary DI 00096295143850
Brand name LEADER
Version or model 5915004
Catalog number 5915004
Company Cardinal Health 110, Inc.
DUNS number 063997360
Product code DXN
GMDN term Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Premarket submission K202757
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Oct 2, 2024
Version date Oct 10, 2024
Description LDR Talking Blood Pressure Monitor with Wide Range Arm Cuff 1 monitor Kit

At a glance

  • None 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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