Lubricity Innovative Oral Spray

GUDID 00864206000109

You First Services, Inc.

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