FDA.reportPublic FDA data

myTAP PAP Nasal Pillow Mask Frame

Primary DI
00851085006131
Brand
myTAP PAP Nasal Pillow Mask Frame
Company
AIRWAY TECHNOLOGIES, LLC
Model
PAP-NP1-002
Published
2016-12-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122350000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122350000TAP PAP NASAL PILLOW MASKAirway Management, Inc.2012-11-01BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851085006131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851085006131008510850061318510850061310851085006131

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP nasal mask, reusableA flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963501148
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851085006247Nylon flexTAP Oral ApplianceTAP-NYL-0012026-05-08
00851085006254Nylon flexTAP Oral Appliance KitKIT NYL1002026-05-08
00851085006209flexTAPTAP-FLEX-1002023-05-25
00851085006216flexTAP KitFLEXTAP2023-05-25
00851085006018MyTAP PAP Nasal Pillow MaskPAP-NP1-0002016-08-13
00851085006025MyTAP PAP Nasal Pillow Mask no headgearPAP-NP1-0012016-08-13
00851085006087TAP-3 oral applianceTAP-32016-08-12
00851085006094TAP-3 Elite oral applianceTAP-3 Elite2016-08-12
00851085006100dreamTAP oral appliancedreamTAP2016-08-13
00851085006001MyTAP oral appliancemytap10002016-08-10
00851085006032TAP-1 componentskit082016-08-13
00851085006049TAP-3 componentskit121742016-08-13
00851085006056TAP-3 Elite componentskit1232016-08-13
00851085006063dreamTAP componentskitdr2016-08-13
00851085006070TAP-1 oral applianceTAP-12016-08-12
00851085006117AM Aligner700-1200-1002016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848530106461CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106478CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106485CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106492CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106508CPAP Mask CushionSunset Healthcare Solutions, Inc.BZD2025-07-22
00848530106522CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-17
00848530106515CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-07-17
00848530106355CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106362Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106379CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106386CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106393CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530106409Nasal CPAP MaskSunset Healthcare Solutions, Inc.BZD2025-06-18
00848530081638CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530085230CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090661CPAP MaskSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090678CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090685CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090692CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090708CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090715CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090722CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090739CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530090746CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097103CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097110CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097127CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097134CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097141CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29
00848530097158CPAP MasksSunset Healthcare Solutions, Inc.BZD2024-07-29