| Primary Device ID | 40302340856414 |
| NIH Device Record Key | 6a638547-94c7-4996-b015-7e47aebc2afa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DUREX Tropical Apple |
| 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 | 00302340856416 [Primary] |
| GS1 | 40302340856414 [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 | 2020-03-12 |
| Device Publish Date | 2020-03-04 |
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