UDI device identifier

HOMEDICS TIE-300-BK

UDI device identifier 00031262101358 · FKA DISTRIBUTING CO., LLC

Key facts

Primary DI 00031262101358
Brand name HOMEDICS
Version or model TIE-300-BK
Company FKA DISTRIBUTING CO., LLC
DUNS number 183280973
Product code FLL
GMDN term Infrared patient thermometer, ear/skin
Premarket submission K182597
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date Jan 31, 2022
Version date Feb 8, 2022
Description Infrared Ear/Forehead Thermometer

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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