| Primary Device ID | 10302340983546 |
| NIH Device Record Key | 02470f43-e52d-476a-ac91-0cbf4a52aa9d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUREX Performax Intense Condom |
| Version Model Number | Condom |
| Company DUNS | 081049410 |
| Company Name | RB Health (us) LLC |
| Device Count | 24 |
| 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00302340983549 [Primary] |
| GS1 | 10302340983546 [Package] Contains: 00302340983549 Package: Carton [2 Units] In Commercial Distribution |
| GS1 | 20302340983543 [Package] Package: Case [9 Units] In Commercial Distribution |
| GS1 | 40302340983547 [Unit of Use] |
| HIS | CONDOM |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-07 |
| Device Publish Date | 2019-10-30 |
| 10302340853290 | Condom |
| 20302340853280 | Condom |
| 20302340853273 | Condom |
| 10302340983546 | Condom |
| 00023408568101 | Condom |
| 40302340856810 | Condom |
| 00302340853286 | Condom |
| 40302340853277 | Condom |