FDA.reportPublic FDA data

Winx®

Primary DI
00852126007247
Brand
Winx®
Company
APNICURE, INC.
Model
M4000-M1
Catalog number
M4000-M1
Device description
Winx HB Mouthpiece, M1
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OZRIntraoral Pressure Gradient Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OZRIntraoral Pressure Gradient DeviceDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852126007247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852126007247008521260072478521260072470852126007247

GMDN Terms#

Term, Definition table
TermDefinition
Breathing mouthpiece, reusableA device designed to be inserted into a patient's mouth to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that provides an appropriate gastight seal (i.e., with a patient's lips) and prevents collapse. The device is typically attached, either directly or through other tubes/adapters, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888 986 6275poconnor@apnicure.com

Regulatory Flags#

DUNS number
008873230
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852126007018Winx®M1000-S1M1000-S12016-09-16
00852126007025Winx®M1000-S2M1000-S22016-09-16
00852126007032Winx®M1000-S3M1000-S32016-09-16
00852126007049Winx®M1000-M1M1000-M12016-09-16
00852126007056Winx®M1000-M2M1000-M22016-09-16
00852126007063Winx®M1000-M3M1000-M32016-09-16
00852126007070Winx®M1000-M4M1000-M42016-09-16
00852126007087Winx®M1000-L2M1000-L22016-09-16
00852126007094Winx®M1000-L3M1000-L32016-09-16
00852126007100Winx®M1000-L4M1000-L42016-09-16
00852126007117Winx®M5000-S1M5000-S12016-09-16
00852126007124Winx®M5000-S2M5000-S22016-09-16
00852126007131Winx®M5000-S3M5000-S32016-09-16
00852126007148Winx®M5000-M1M5000-M12016-09-16
00852126007155Winx®M5000-M2M5000-M22016-09-16
00852126007162Winx®M5000-M3M5000-M32016-09-16
00852126007179Winx®M5000-M4M5000-M42016-09-16
00852126007186Winx®M5000-L2M5000-L22016-09-16
00852126007193Winx®M5000-L3M5000-L32016-09-16
00852126007209Winx®M5000-L4M5000-L42016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719878320122iNAPSOMNICS, INC.OZR2024-02-05
04719878321525iNAPSOMNICS, INC.OZR2024-02-05
04719878321532iNAPSOMNICS, INC.OZR2024-02-05
04719878321099iNAP One SOMNICS, INC.OZR2023-03-07
04719878321105iNAP One SOMNICS, INC.OZR2023-03-07
04719878321075iNAP One SOMNICS, INC.OZR2023-03-06
04719878320856SomnicsSOMNICS, INC.OZR2022-11-28
04719878320108iNAP One SOMNICS, INC.OZR2022-06-15
04719878320528iNAP One SOMNICS, INC.OZR2022-06-15
04719878320535iNAP One SOMNICS, INC.OZR2022-06-15
04719878320542iNAP One SOMNICS, INC.OZR2022-06-15
04719878320023iNAPSOMNICS, INC.OZR2022-06-01
04719878320061iNAPSOMNICS, INC.OZR2022-06-01
04719878320559iNAPSOMNICS, INC.OZR2022-06-01
04719878320887iNAP One SOMNICS, INC.OZR2022-06-01
04719878320511iNAPSOMNICS, INC.OZR2021-07-21
04719878320184iNAPSOMNICS, INC.OZR2021-07-13
04719878320252iNAPSOMNICS, INC.OZR2021-06-03
04719878320047iNAPSOMNICS, INC.OZR2020-12-23
04719878320009iNAPSOMNICS, INC.OZR2020-09-23
04719878320030iNAPSOMNICS, INC.OZR2020-09-23
04719878320078iNAPSOMNICS, INC.OZR2020-09-23
04719878320092iNAPSOMNICS, INC.OZR2020-09-23
04719878320115iNAPSOMNICS, INC.OZR2020-09-23
00852126007001Winx®APNICURE, INC.OZR2016-09-16
00852126007018Winx®APNICURE, INC.OZR2016-09-16
00852126007025Winx®APNICURE, INC.OZR2016-09-16
00852126007032Winx®APNICURE, INC.OZR2016-09-16
00852126007049Winx®APNICURE, INC.OZR2016-09-16
00852126007056Winx®APNICURE, INC.OZR2016-09-16