Biotene

GUDID 00048582285422

Biotene Oral Rinse 33.8 oz Twin Pack

Glaxosmithkline Consumer Healthcare Holdings (us) LLC

Artificial saliva

• Primary Device ID: 00048582285422
• NIH Device Record Key: 76bf9e25-c4d9-440a-94b1-e36c40ff6d95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotene
• Version Model Number: Oral Rinse Twin Pack
• Company DUNS: 079944263
• Company Name: Glaxosmithkline Consumer Healthcare Holdings (us) LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00048582285422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123731

FDA Product Code

• LFD: Saliva, Artificial

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-24
• Device Publish Date: 2023-04-14

On-Brand Devices [Biotene]

• 00048582802209: Biotene Oral Rinse Dry Mouth 1x8.0 oz
• 00048582512016: Biotene Oral Balance Gel 1x42g
• 00048582350410: Biotene Oral Rinse Twin Pack 2x33.8 oz
• 00048582285422: Biotene Oral Rinse 33.8 oz Twin Pack
• 00048582120266: Biotene Ecommerce Variety Pack Rinse Spray
• 00048582100077: Biotene Dry Mouth Sample 15 mL
• 00048582004580: Biotene Dry Mouth Gentle Oral Rinse 33.8 oz
• 00048582004566: Biotene Dry Mouth Gentle Oral Rinse 16 oz
• 00048582003309: Biotene Dry Mouth Oral Rinse 16 oz
• 00048582001558: Biotene Mouth Spray 1.5 oz