| Primary Device ID | 00851085006094 |
| NIH Device Record Key | fb267cb8-9b37-44d9-afa5-e2df2c188b48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TAP-3 Elite oral appliance |
| Version Model Number | TAP-3 Elite |
| Company DUNS | 963501148 |
| Company Name | AIRWAY TECHNOLOGIES, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851085006094 [Primary] |
| LRK | Device, Anti-Snoring |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-12 |
| 00851085006209 - flexTAP | 2023-06-02 The flex Thornton Adjustable Positioner™ (flexTAP™) is intended to reduce or alleviate nighttime snoring and sleep related b |
| 00851085006216 - flexTAP Kit | 2023-06-02 The flex Thornton Adjustable Positioner™ (flexTAP™) is intended to reduce or alleviate nighttime snoring and sleep related b |
| 00851085006018 - MyTAP PAP Nasal Pillow Mask | 2018-07-06 |
| 00851085006025 - MyTAP PAP Nasal Pillow Mask no headgear | 2018-07-06 |
| 00851085006087 - TAP-3 oral appliance | 2018-07-06 |
| 00851085006094 - TAP-3 Elite oral appliance | 2018-07-06 |
| 00851085006094 - TAP-3 Elite oral appliance | 2018-07-06 |
| 00851085006100 - dreamTAP oral appliance | 2018-07-06 |
| 00851085006131 - myTAP PAP Nasal Pillow Mask Frame | 2018-07-06 |