UDI device identifier

Omron Easy Wrap Comfit Cuff HEM-FL31-B

UDI device identifier 00073796361723 · Omron Healthcare, Inc.

Key facts

Primary DI 00073796361723
Brand name Omron Easy Wrap Comfit Cuff
Version or model HEM-FL31-B
Catalog number HEM-FL31-B
Company Omron Healthcare, Inc.
DUNS number 054318779
Product code DXN
GMDN term Blood pressure cuff, reusable
Premarket submission K133383
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date May 1, 2019
Version date Jun 12, 2025
Description Optional blood pressure monitor cuff, preformed 9" to 17"

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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