FDA.reportPublic FDA data

MyTAP PAP Nasal Pillow Mask no headgear

Primary DI
00851085006025
Brand
MyTAP PAP Nasal Pillow Mask no headgear
Company
AIRWAY TECHNOLOGIES, LLC
Model
PAP-NP1-001
Published
2016-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00851085006025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851085006025008510850060258510850060250851085006025

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
00851085006087TAP-3 oral applianceTAP-32016-08-12
00851085006094TAP-3 Elite oral applianceTAP-3 Elite2016-08-12
00851085006100dreamTAP oral appliancedreamTAP2016-08-13
00851085006131myTAP PAP Nasal Pillow Mask FramePAP-NP1-0022016-12-29
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
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109042CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109059CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109066CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00814747024850Novaplus Pediatric Nasal Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024867Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024874Novaplus Pediatric Nasal Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024881Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03
00814747024898Novaplus Pediatric Nasal Non Vented Mask, Extra SmallSLEEPNET, CORP.BZD2026-06-03
00814747024904Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-03
00814747024911Novaplus Pediatric Nasal Non Vented Mask, MediumSLEEPNET, CORP.BZD2026-06-03
00814747024928Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-03
00848530109097CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109264CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109271CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
00848530109288CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-03
04719893348873WellellWellell Inc.BZD2026-06-01
09420012464668Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-19
09420012423573Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBZD2026-03-18
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