| Primary Device ID | 00302340300452 |
| NIH Device Record Key | 29812b79-7b16-4510-bf12-c7de234b460f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUREX Classic XXL and DUREX Classic Condom |
| Version Model Number | Condom |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00302340300438 [Package] Contains: 99302340300456 Package: Carton [12 Units] In Commercial Distribution |
| GS1 | 00302340300452 [Package] Contains: 99302340300456 Package: Carton [3 Units] In Commercial Distribution |
| GS1 | 20302340300456 [Package] Package: Case [144 Units] In Commercial Distribution |
| GS1 | 50302340300433 [Package] Contains: 00302340300438 Package: Case [18 Units] In Commercial Distribution |
| GS1 | 99302340300456 [Primary] |
| HIS | CONDOM |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-10-02 |
| Device Publish Date | 2023-07-13 |
| 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. |