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
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00850088881042IBEETShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881059MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881066MEDICOLORShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-14
00850088881028ItAllShenzhen Sany Pioneer Technology Co.,LtdBZD2026-07-09
00198843003347Infant Flow™Zoll Medical CorporationBZD2026-06-24
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00198843003385Infant Flow™Zoll Medical CorporationBZD2026-06-24
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00198843003422Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003545Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003552Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003569Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003576Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003583Infant Flow™Zoll Medical CorporationBZD2026-06-24
00198843003590Infant Flow™Zoll Medical CorporationBZD2026-06-24
00814747024935MiniMe 2 Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024942MiniMe 2 Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024959MiniMe 2 Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024966MiniMe 2 Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747024973Novaplus Pediatric Nasal Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024980Novaplus Pediatric Nasal Non Vented Mask, SmallSLEEPNET, CORP.BZD2026-06-22
00814747024997Novaplus Pediatric Nasal Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
00814747025000Novaplus Pediatric Nasal Non Vented Mask, LargeSLEEPNET, CORP.BZD2026-06-22
04048675824121Seattle PAPDrägerwerk AG & Co. KGaABZD2026-06-11
00848530108984CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530108991CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04
00848530109004CPAP MaskSUNSET HEALTHCARE SOLUTIONS, INC.BZD2026-06-04