UDI device identifier

Omron Heart Guide Wrist Blood Pressure Monitor, Large BP8000-L

UDI device identifier 00073796268022 · Omron Healthcare, Inc.

Key facts

Primary DI 00073796268022
Brand name Omron Heart Guide Wrist Blood Pressure Monitor, Large
Version or model BP8000-L
Catalog number BP8000-L
Company Omron Healthcare, Inc.
DUNS number 054318779
Product code DXN
GMDN term Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Premarket submission K190693
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Sep 13, 2019
Version date Nov 8, 2019
Description Wearable Wrist Blood Pressure Monitor with Fitness and Sleep Tracking

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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