LubriGel 08103024

GUDID 00732953081033

Sheffield LubriGel is a FDA clear class 2 device sold as a personal lubricant filled into a 3.0 OZ tube packed into a carton

SHEFFIELD PHARMACEUTICALS, LLC

Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant Vaginal lubricant

• Primary Device ID: 00732953081033
• NIH Device Record Key: a360c4db-e80d-4c54-ab07-1d072cea47a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LubriGel
• Version Model Number: 5442103
• Catalog Number: 08103024
• Company DUNS: 151177797
• Company Name: SHEFFIELD PHARMACEUTICALS, 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: 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

Customer Support Contacts

• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com
• Phone: 8604424451
• Email: anthony.sollima@sheffieldpharma.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732953081033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001077

FDA Product Code

• NUC: Lubricant, Personal

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: 2023-06-16
• Device Publish Date: 2023-06-08