Primary Device ID | 00851085006087 |
NIH Device Record Key | 497aff20-a9dc-4f0d-b344-a82d737748db |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TAP-3 oral appliance |
Version Model Number | TAP-3 |
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 | 00851085006087 [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 |
00851085006087 - TAP-3 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 |