Serenade Tinnitus Treatment System

Primary DI
00861259000209
Brand
Serenade Tinnitus Treatment System
Company
SOUNDCURE, INC.
Model
900000
Published
2016-09-01
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
KLWMasker, Tinnitus

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLWMasker, TinnitusEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861259000209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861259000209008612590002098612590002090861259000209

GMDN Terms#

Term, Definition table
TermDefinition
In-the-ear air-conduction tinnitus masker, digitalA battery-powered digital acoustic device designed to provide noise of sufficient intensity and bandwidth to mask (make less noticeable and provide temporary relief from) tinnitus (a ringing sound in the ear or internal head noises). It typically consists of a miniature sound generator, contained in a case that fits completely inside the outer ear (concha) [in-the-ear (ITE)], that delivers the noise to the eardrum through air. The microphone in some types may measure the level of the background noise and adjust accordingly the masking signal. The digital design of the device allows for the introduction of new tinnitus masking software programs.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
408-938-5745customerservice@soundcure.com

Regulatory Flags#

DUNS number
052252810
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05708296394029BeltoneGn Hearing A/SKLW2026-10-05
05708296394036BeltoneGn Hearing A/SKLW2026-10-05
05708296394098BeltoneGn Hearing A/SKLW2026-10-05
05708296394104BeltoneGn Hearing A/SKLW2026-10-05
05708296394111BeltoneGn Hearing A/SKLW2026-10-05
05708296394128BeltoneGn Hearing A/SKLW2026-10-05
05708296394135BeltoneGn Hearing A/SKLW2026-10-05
05708296394197BeltoneGn Hearing A/SKLW2026-10-05
05708296394203BeltoneGn Hearing A/SKLW2026-10-05
05708296394210BeltoneGn Hearing A/SKLW2026-10-05
05708296394487BeltoneGn Hearing A/SKLW2026-10-05
05708296394494BeltoneGn Hearing A/SKLW2026-10-05
05708296394555BeltoneGn Hearing A/SKLW2026-10-05
05708296394562BeltoneGn Hearing A/SKLW2026-10-05
05708296394579BeltoneGn Hearing A/SKLW2026-10-05
05708296394586BeltoneGn Hearing A/SKLW2026-10-05
05708296394593BeltoneGn Hearing A/SKLW2026-10-05
05708296394654BeltoneGn Hearing A/SKLW2026-10-05
05708296394661BeltoneGn Hearing A/SKLW2026-10-05
05708296394678BeltoneGn Hearing A/SKLW2026-10-05
05708296397877BeltoneGn Hearing A/SKLW2026-10-05
05708296397884BeltoneGn Hearing A/SKLW2026-10-05
05708296397945BeltoneGn Hearing A/SKLW2026-10-05
05708296397952BeltoneGn Hearing A/SKLW2026-10-05
05708296397969BeltoneGn Hearing A/SKLW2026-10-05
05708296429455BeltoneGn Hearing A/SKLW2026-10-05
05708296429462BeltoneGn Hearing A/SKLW2026-10-05
05708296429523BeltoneGn Hearing A/SKLW2026-10-05
05708296429530BeltoneGn Hearing A/SKLW2026-10-05
05708296429547BeltoneGn Hearing A/SKLW2026-10-05