| Primary Device ID | 20679810872608 |
| NIH Device Record Key | 11573a25-ded5-4f13-b2ea-b57d56bb2d94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KY Intense Condoms |
| 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 n |
| 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 |
| 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 | 00679810872604 [Primary] |
| GS1 | 10679810872601 [Unit of Use] |
| GS1 | 20679810872608 [Package] Contains: 00679810872604 Package: Carton [18 Units] In Commercial Distribution |
| 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 | 2018-12-13 |
| Device Publish Date | 2018-10-31 |
| 20679810872707 | Condom |
| 20679810872608 | Condom |
| 20679810872509 | Condom |
| 20067981087264 | Condom |
| 10067981087250 | Condom |
| 20067981087769 | Condom |
| 10067981087274 | Condom |