UDI device identifier

Biotene Dry Mouth Gentle Oral Rinse

UDI device identifier 00048582004580 · Haleon US Holdings LLC

Key facts

Primary DI 00048582004580
Brand name Biotene
Version or model Dry Mouth Gentle Oral Rinse
Company Haleon US Holdings LLC
DUNS number 079944263
Product code LFD
GMDN term Artificial saliva
Premarket submission K123731
Device class Unclassified
Single use Yes
Packaged sterile No
Implantable No
Publish date Apr 14, 2023
Version date Aug 5, 2024
Description Biotene Dry Mouth Gentle Oral Rinse 33.8 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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