UDI device identifier

Biotene Mouth Spray

UDI device identifier 00048582001558 · Haleon US Holdings LLC

Key facts

Primary DI 00048582001558
Brand name Biotene
Version or model Mouth Spray
Company Haleon US Holdings LLC
DUNS number 079944263
Product code LFD
GMDN term Artificial saliva
Premarket submission K103745
Device class Unclassified
Single use Yes
Packaged sterile No
Implantable No
Publish date Apr 14, 2023
Version date Feb 27, 2024
Description Biotene Mouth Spray 1.5 oz

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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