| Primary Device ID | 00023408568101 |
| NIH Device Record Key | 97066d0c-efa8-4f62-a2b1-192c97df7d0d |
| Commercial Distribution Discontinuation | 2016-12-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | DUREX Performax Intense Condom |
| Version Model Number | Condom |
| Company DUNS | 081049410 |
| Company Name | RB Health (us) LLC |
| Device Count | 1000 |
| 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 | 00023408568101 [Primary] |
| GS1 | 10023408568108 [Unit of Use] |
| HIS | CONDOM |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2019-11-18 |
| Device Publish Date | 2016-09-20 |
| 10302340853290 | Condom |
| 20302340853280 | Condom |
| 20302340853273 | Condom |
| 10302340983546 | Condom |
| 00023408568101 | Condom |
| 40302340856810 | Condom |
| 00302340853286 | Condom |
| 40302340853277 | Condom |
| 50302340995776 | DUREX Performax Intense Condom 42ct. |
| 50302340853298 | DUREX Performax Intense Condom 24ct. |
| 50302340853281 | DUREX Performax Intense Condom 12ct. |
| 50302340853274 | DUREX Performax Intense Condom 3ct. |