MyTAP PAP Nasal Pillow Mask

GUDID 00851085006018

AIRWAY TECHNOLOGIES, LLC

CPAP/BPAP nasal mask, reusable
Primary Device ID00851085006018
NIH Device Record Keyd3ffbbd6-3731-4ef4-b46b-dac977d555a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyTAP PAP Nasal Pillow Mask
Version Model NumberPAP-NP1-000
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 Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100851085006018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-13

Devices Manufactured by AIRWAY TECHNOLOGIES, LLC

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
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.