FDA.reportPublic FDA data

GN ReSound

Primary DI
05708296095759
Brand
GN ReSound
Company
Gn Hearing A/S
Model
20734500
Device description
SW,FSW,COSTCO SMART FIT 1.2
Published
2018-10-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05708296095759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296095759057082960957595708296095759

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or hearing assistive devices. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-888-735-4327consumerhelp@gnresound.com

Regulatory Flags#

DUNS number
306179227
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05708296456383GN Hearing242827002026-05-19
05708296456390GN Hearing242828002026-05-19
05708296458349GN Hearing242927002026-05-19
05708296473359GN Hearing242945002026-05-19
05708296382491GN ReSound236197002026-04-28
05708296434459GN Hearing239357002026-04-28
05708296434473GN Hearing239359002026-04-28
05708296434541GN Hearing239366002026-04-28
05708296434565GN Hearing239368002026-04-28
05708296435913GN Hearing240701002026-04-28
05708296435944GN Hearing240704002026-04-28
05708296435951GN Hearing240705002026-04-28
05708296435999GN Hearing240709002026-04-28
05708296436019GN Hearing240711002026-04-28
05708296436026GN Hearing240712002026-04-28
05708296436040GN Hearing240714002026-04-28
05708296436088GN Hearing240718002026-04-28
05708296436101GN Hearing240720002026-04-28
05708296436125GN Hearing240722002026-04-28
05708296390243GN Hearing237709002026-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05714880292077WidexWidex A/SOSM2026-05-22
05714880292084WidexWidex A/SOSM2026-05-22
05714880292091WidexWidex A/SOSM2026-05-22
05714880292107WidexWidex A/SOSM2026-05-22
05714880292114WidexWidex A/SOSM2026-05-22
05714880292121WidexWidex A/SOSM2026-05-22
05714880292138WidexWidex A/SOSM2026-05-22
05714880292145WidexWidex A/SOSM2026-05-22
05714880292152WidexWidex A/SOSM2026-05-22
05714880292169WidexWidex A/SOSM2026-05-22
05714880292176WidexWidex A/SOSM2026-05-22
05714880292183WidexWidex A/SOSM2026-05-22
05714880292190WidexWidex A/SOSM2026-05-22
05714880292206WidexWidex A/SOSM2026-05-22
05714880292213WidexWidex A/SOSM2026-05-22
05714880292220WidexWidex A/SOSM2026-05-22
05714880292237WidexWidex A/SOSM2026-05-22
05714880292244WidexWidex A/SOSM2026-05-22
05714880292251WidexWidex A/SOSM2026-05-22
05714880292268WidexWidex A/SOSM2026-05-22
05714880292275WidexWidex A/SOSM2026-05-22
05714880292282WidexWidex A/SOSM2026-05-22
05714880292299WidexWidex A/SOSM2026-05-22
05714880292305WidexWidex A/SOSM2026-05-22
05714880292312WidexWidex A/SOSM2026-05-22
05714880292329WidexWidex A/SOSM2026-05-22
05714880292336WidexWidex A/SOSM2026-05-22
05714880292343WidexWidex A/SOSM2026-05-22
05714880292350WidexWidex A/SOSM2026-05-22
05714880292367WidexWidex A/SOSM2026-05-22