Lubricity Innovative Oral Spray

GUDID 00864206000109

You First Services, Inc.

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: 00864206000109
• NIH Device Record Key: 65e54ef5-c80e-4dee-8b09-87384af2b122
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lubricity Innovative Oral Spray
• Version Model Number: 2.0 Fluid Ounces
• Company DUNS: 061191200
• Company Name: You First Services, Inc.
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864206000109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163476

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: 2022-07-18
• Device Publish Date: 2022-07-08

On-Brand Devices [Lubricity Innovative Oral Spray]

• 00864206000123: 0.5 Fluid Ounces
• 00864206000109: 2.0 Fluid Ounces