FDA.reportPublic FDA data

Winx®

Primary DI
00852126007353
Brand
Winx®
Company
APNICURE, INC.
Model
A1005-00
Catalog number
A1005-00
Device description
Winx Power Cord
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
00852126007353PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852126007353008521260073538521260073530852126007353

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. 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