flexTAP Kit

GUDID 00851085006216

The flex Thornton Adjustable Positioner™ (flexTAP™) is intended to reduce or alleviate nighttime snoring and sleep related breathing disorders including obstructive sleep apnea (OSA). The flexTAP™ is a custom-made oral device intended to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA). The flexTAP™ device consists of an Upper Tray that fits over the upper teeth and Lower Tray that fits over the lower teeth.

AIRWAY TECHNOLOGIES, LLC

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00851085006216
• NIH Device Record Key: ce81fe26-b1bd-4e4b-bc2b-7612dee3a8ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: flexTAP Kit
• Version Model Number: FLEXTAP
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851085006216 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061732

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-02
• Device Publish Date: 2023-05-25

Devices Manufactured by AIRWAY TECHNOLOGIES, LLC

• 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: 2023-06-02The flex Thornton Adjustable Positioner™ (flexTAP™) is intended to reduce or alleviate nighttime snoring and sleep related breathing disorders including obstructive sleep apnea (OSA). The flexTAP™ is a custom-made oral device intended to reduce or alleviate nighttime snoring and obstructive sleep apnea (OSA). The flexTAP™ device consists of an Upper Tray that fits over the upper teeth and Lower Tray that fits over the lower teeth.
• 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
• 00851085006100 - dreamTAP oral appliance: 2018-07-06
• 00851085006131 - myTAP PAP Nasal Pillow Mask Frame: 2018-07-06