| Primary Device ID | 99067981993756 |
| NIH Device Record Key | ebb74ba0-737a-43b1-959a-80de645fa0c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KY UltraGel |
| Version Model Number | Personal Lubricant |
| Company DUNS | 081049410 |
| Company Name | RB Health (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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx | |
| Phone | 1 800-756-5488 |
| xxx@xxx.xxx |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep out of reach of children. Slippery, avoid spills. Store in a cool dry place away from direct sunlight. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00067981993752 [Package] Package: Carton [1 Units] In Commercial Distribution |
| GS1 | 00067981993936 [Package] Package: Carton [8 Units] In Commercial Distribution |
| GS1 | 10067981993759 [Package] Contains: 00067981993752 Package: Case [24 Units] In Commercial Distribution |
| GS1 | 10067981993933 [Package] Contains: 00067981993936 Package: Case [12 Units] In Commercial Distribution |
| GS1 | 99067981993756 [Primary] |
| NUC | Lubricant, Personal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-12 |
| Device Publish Date | 2023-04-04 |
| 00302340995931 - Durex Intense XL | 2025-09-09 10 ct. Durex Intense XL Nitrile Condom |
| 50302340995998 - Durex Intense XL | 2025-09-09 3 ct. Durex Intense XL Nitrile Condom |
| 50302340996001 - Durex Intense XL | 2025-09-09 24 ct. Durex Intense XL Nitrile Condom |
| 50302340996018 - Durex Intense Ultra Lube | 2025-09-09 10 ct. Durex Intense Ultra Lube Nitrile Condom |
| 50302340996025 - Durex Intense Ultra Lube | 2025-09-09 24 ct. Durex Intense Ultra Lube Nitrile Condom |
| 10067981993780 - K-Y® Hydrablend | 2025-07-18 1.5 oz. KY Hydrablend Hybrid Personal Lubricant |
| 00067981993790 - K-Y® Hydrablend | 2025-07-18 4.5 oz. KY Hydrablend Hybrid Personal Lubricant |
| 00067981087116 - KY Warming Liquid Lubricant | 2025-06-09 Personal Lubricant - 2.4oz. |