UDI device identifier

Leader 5279823

UDI device identifier 00096295129328 · Cardinal Health 110, Inc.

Key facts

Primary DI 00096295129328
Brand name Leader
Version or model 5279823
Catalog number 5279823
Company Cardinal Health 110, Inc.
DUNS number 063997360
Product code DXN
GMDN term Aneroid manual sphygmomanometer
Premarket submission K082542
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Mar 23, 2017
Version date Jul 5, 2021
Description LDR Blood Pressure Home Kit with manual Stethoscope

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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