| Primary Device ID | 00850002174236 |
| NIH Device Record Key | d3a990ca-c534-4d08-8ced-f0af46da8b0a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONE |
| Version Model Number | GS134 |
| Company DUNS | 106855461 |
| Company Name | LUNAMAX 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850002174236 [Primary] |
| HIS | Condom |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-28 |
| Device Publish Date | 2018-11-27 |
| 00850002174786 | ONE Pleasure Plus Latex Condoms |
| 00850002174762 | ONE Chocolate Mint Flavored Latex Condom |
| 00850002174755 | ONE Banana Split Flavored Latex Condom |
| 00850002174748 | ONE Fresh Mint Flavored Latex Condom |
| 00850002174731 | ONE Chocolate Strawberry Flavored Latex Condom |
| 00850002174724 | ONE Island Punch Flavored Latex Condom |
| 00850002174717 | ONE Bubblegum Flavored Latex Condom |
| 00850002174663 | ONE Super Sensitive Latex Condom |
| 00850002174656 | ONE Color Sensations Latex Condom |
| 00850002174649 | ONE Glowing Pleasures Latex Condom |
| 00850002174427 | ONE Flavor Waves Flavored Latex Condom |
| 00850002174410 | ONE Super Studs Latex Condoms |
| 00850002174373 | ONE Pleasure Dome Latex Condom |
| 00850002174366 | ONE Tattoo Touch Latex Condom |
| 00850002174359 | ONE Legend Latex Condom |
| 00850002174342 | ONE Legend Latex Condom |
| 00850002174250 | ONE Vanish Latex Condom |
| 00850002174243 | ONE Zero Thin Latex Condom |
| 00850002174236 | ONE Zero Thin Latex Condom |
| 00850002174120 | ONE Vanish Latex Condom |