FDA.reportPublic FDA data

GN ReSound

Primary DI
05708296150588
Brand
GN ReSound
Company
Gn Hearing A/S
Model
20918112
Device description
USB,SMART F 1.2#1,US
Published
2018-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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
05708296150588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05708296150588057082961505885708296150588

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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

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Primary DI, Brand, Company table
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