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| 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 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| anthony.sollima@sheffieldpharma.com | |
| Phone | 8604424451 |
| 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 |
Trademark Results [LubriGel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUBRIGEL 78541753 not registered Dead/Abandoned |
Sheffield Laboratories, Div. Faria Limited LLC 2005-01-04 |
 LUBRIGEL 73627035 1638774 Dead/Cancelled |
PERCHEM LIMITED 1986-10-27 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.