UDI device identifier

HOMEDICS TENS-150J

UDI device identifier 00031262108500 · FKA DISTRIBUTING CO., LLC

Key facts

Primary DI 00031262108500
Brand name HOMEDICS
Version or model TENS-150J
Company FKA DISTRIBUTING CO., LLC
DUNS number 183280973
Product code NUH
GMDN term Analgesic transcutaneous electrical nerve stimulation system
Premarket submission K130723
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Mar 15, 2024
Version date Mar 25, 2024
Description TENS & EMS pain therapy

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 100–999 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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