Biotene Oral Rinse Dry Mouth

GUDID 00048582004405

Biotene Oral Rinse Dry Mouth 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: 00048582004405
• NIH Device Record Key: db36d159-ae25-4f1b-b746-b0bccd930ff8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biotene Oral Rinse Dry Mouth
• Version Model Number: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00048582004405 [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: 2023-04-11
• Device Publish Date: 2023-04-03

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