UDI device identifier

Biotene Oral Rinse Twin Pack

UDI device identifier 00048582285422 · Haleon US Holdings LLC

Key facts

Primary DI 00048582285422
Brand name Biotene
Version or model Oral Rinse Twin Pack
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 Oral Rinse 33.8 oz Twin Pack

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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