Biotene

GUDID 00048582004580

Biotene Dry Mouth Gentle Oral Rinse 33.8 oz

Glaxosmithkline Consumer Healthcare Holdings (us) LLC

Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva Artificial saliva

• Primary Device ID: 00048582004580
• NIH Device Record Key: 766edd17-9a90-45dc-86d3-6826207c5581
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotene
• Version Model Number: Dry Mouth Gentle Oral Rinse
• 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	00048582004580 [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