UDI device identifier

Omron Gold, Wrist Blood Pressure Monitor BP4350

UDI device identifier 00073796264352 · Omron Healthcare, Inc.

Key facts

Primary DI 00073796264352
Brand name Omron Gold, Wrist Blood Pressure Monitor
Version or model BP4350
Catalog number BP4350
Company Omron Healthcare, Inc.
DUNS number 054318779
Product code DXN
GMDN term Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Premarket submission K182166
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Jul 8, 2019
Version date Jun 12, 2025
Description Wrist Blood Pressure - 100 readings per user (2 users), Bluetooth Connectivity, Ultra Silent Inflation.

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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