UDI device identifier

Omron TENS Total Power + Heat for Canada PM800CAN

UDI device identifier 00073796800314 · Omron Healthcare, Inc.

Key facts

Primary DI 00073796800314
Brand name Omron TENS Total Power + Heat for Canada
Version or model PM800CAN
Catalog number PM800CAN
Company Omron Healthcare, Inc.
DUNS number 054318779
Product code NYN
GMDN term Analgesic transcutaneous electrical nerve stimulation system
Premarket submission K181992
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Jan 15, 2020
Version date Jan 23, 2020
Description Omron TENS Total Power + Heat is a portable, battery-operated device that is designed to relieve muscle and joint pain.

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 10–99 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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