flexTAP

GUDID 00851085006209

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 ID00851085006209
NIH Device Record Keyd2b318ce-08a4-48fc-be8b-a77793497fed
Commercial Distribution StatusIn Commercial Distribution
Brand NameflexTAP
Version Model NumberTAP-FLEX-100
Company DUNS963501148
Company NameAIRWAY TECHNOLOGIES, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100851085006209 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LRKDevice, Anti-Snoring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-02
Device Publish Date2023-05-25

Devices Manufactured by AIRWAY TECHNOLOGIES, LLC

00851085006209 - flexTAP2023-06-02The 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.
00851085006209 - flexTAP2023-06-02 The flex Thornton Adjustable Positioner™ (flexTAP™) is intended to reduce or alleviate nighttime snoring and sleep related b
00851085006216 - flexTAP Kit2023-06-02 The flex Thornton Adjustable Positioner™ (flexTAP™) is intended to reduce or alleviate nighttime snoring and sleep related b
00851085006018 - MyTAP PAP Nasal Pillow Mask2018-07-06
00851085006025 - MyTAP PAP Nasal Pillow Mask no headgear2018-07-06
00851085006087 - TAP-3 oral appliance2018-07-06
00851085006094 - TAP-3 Elite oral appliance2018-07-06
00851085006100 - dreamTAP oral appliance2018-07-06
00851085006131 - myTAP PAP Nasal Pillow Mask Frame2018-07-06

Trademark Results [flexTAP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FLEXTAP
FLEXTAP
90835480 not registered Live/Pending
Airway Technologies, LLC
2021-07-19
FLEXTAP
FLEXTAP
87080655 not registered Dead/Abandoned
Communications Systems, Inc.
2016-06-22
FLEXTAP
FLEXTAP
76167797 2772131 Live/Registered
SCHOLLE IPN CORPORATION
2000-11-17
FLEXTAP
FLEXTAP
73839790 1634156 Dead/Cancelled
ART STONE THEATRICAL CORP.
1989-11-15

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