FDA.reportPublic FDA data

Widex

Primary DI
05714880296396
Brand
Widex
Company
Widex A/S
Model
KIT MOMENT MRRLD 440 RB
Catalog number
21055028
Device description
KIT SMARTRIC R D 440 RB RGD
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLWMasker, Tinnitus
OSMHearing aid, air conduction with wireless technology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05714880296396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05714880296396057148802963965714880296396

Contacts#

Phone, Email table
PhoneEmail
+4544355600widex@widex.com

Regulatory Flags#

DUNS number
309843613
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05714880296181WidexKIT MOMENT MRRLD DEMO RB210550492026-10-30
05714880296198WidexKIT MOMENT MRRLD RB210550482026-10-30
05714880296204WidexKIT MOMENT MRRLD RB210550472026-10-30
05714880296211WidexKIT MOMENT MRRLD RB210550462026-10-30
05714880296228WidexKIT MOMENT MRRLD RB210550452026-10-30
05714880296235WidexKIT MOMENT MRRLD RB210550442026-10-30
05714880296242WidexKIT MOMENT MRRLD 110 RB210550432026-10-30
05714880296259WidexKIT MOMENT MRRLD 110 RB210550422026-10-30
05714880296266WidexKIT MOMENT MRRLD 110 RB210550412026-10-30
05714880296273WidexKIT MOMENT MRRLD 110 RB210550402026-10-30
05714880296280WidexKIT MOMENT MRRLD 110 RB210550392026-10-30
05714880296297WidexKIT MOMENT MRRLD 220 RB210550382026-10-30
05714880296303WidexKIT MOMENT MRRLD 220 RB210550372026-10-30
05714880296310WidexKIT MOMENT MRRLD 220 RB210550362026-10-30
05714880296327WidexKIT MOMENT MRRLD 220 RB210550352026-10-30
05714880296334WidexKIT MOMENT MRRLD 220 RB210550342026-10-30
05714880296341WidexKIT MOMENT MRRLD 330 RB210550332026-10-30
05714880296358WidexKIT MOMENT MRRLD 330 RB210550322026-10-30
05714880296365WidexKIT MOMENT MRRLD 330 RB210550312026-10-30
05714880296372WidexKIT MOMENT MRRLD 330 RB210550302026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880300116TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300116TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300123TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300123TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300130TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300130TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880300147TRUHEARINGWs Audiology Usa, Inc.KLW2026-11-02
05714880300147TRUHEARINGWs Audiology Usa, Inc.OSM2026-11-02
05714880296181WidexWidex A/SKLW2026-10-30
05714880296181WidexWidex A/SOSM2026-10-30
05714880296198WidexWidex A/SKLW2026-10-30
05714880296198WidexWidex A/SOSM2026-10-30
05714880296204WidexWidex A/SKLW2026-10-30
05714880296204WidexWidex A/SOSM2026-10-30
05714880296211WidexWidex A/SOSM2026-10-30
05714880296211WidexWidex A/SKLW2026-10-30
05714880296228WidexWidex A/SKLW2026-10-30
05714880296228WidexWidex A/SOSM2026-10-30
05714880296235WidexWidex A/SKLW2026-10-30
05714880296235WidexWidex A/SOSM2026-10-30
05714880296242WidexWidex A/SKLW2026-10-30
05714880296242WidexWidex A/SOSM2026-10-30
05714880296259WidexWidex A/SKLW2026-10-30
05714880296259WidexWidex A/SOSM2026-10-30
05714880296266WidexWidex A/SKLW2026-10-30
05714880296266WidexWidex A/SOSM2026-10-30
05714880296273WidexWidex A/SKLW2026-10-30
05714880296273WidexWidex A/SOSM2026-10-30
05714880296280WidexWidex A/SKLW2026-10-30
05714880296280WidexWidex A/SOSM2026-10-30