Sonic

GUDID 05711583038216

SOUNDLINK 2 2.1.0 IOS

Sonic Innovations, Inc.

Hearing aid wireless-fitting computer-aided set Hearing aid wireless-fitting computer-aided set Hearing aid wireless-fitting computer-aided set
Primary Device ID05711583038216
NIH Device Record Key0c183a94-adb5-42eb-9e86-c5eff8c1658b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSonic
Version Model Number214710
Company DUNS968696919
Company NameSonic Innovations, Inc.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4539177100
Emaileand@demant.com
Phone+4539177100
Emaileand@demant.com
Phone+4539177100
Emaileand@demant.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105711583038216 [Primary]
GS105711583038216 [Primary]
GS105711583038216 [Primary]

FDA Product Code

KLWMasker, tinnitus
KLWMasker, tinnitus
KLWMasker, tinnitus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [Sonic]

05711584074701SOUNDLINK 2 1.4 ANDROID
05711584074695SOUNDLINK 2 1.4 IOS
05711584058169NE1 ITCD, WL L BE NEVARA 1
05711584058152NE1 ITCD, WL R BE NEVARA 1
05711584058145NE1 ITC, L BE NEVARA 1
05711584058138NE1 ITC, R BE NEVARA 1
05711584058121NE1 ITED, WL L BE NEVARA 1
05711584058114NE1 ITED, WL R BE NEVARA 1
05711584058107NE1 CICP, WL BE NEVARA 1
05711584058091NE1 CICX, WL BE NEVARA 1
05711584052266BL100 NR, PS MAC DEMO BLISS 100
05711584052259BL100 NR, PS MAC BLISS 100
05711584020210VR9 ITCD, RC WL AT L BE VERAS 9
05711584020111VR5 ITCD, RC WL AT L BE VERAS 5
05711584020104VR5 ITCD, RC WL AT R BE VERAS 5
05711584002889VR5 ITCDx, RC WL AT L BE VERAS 5
05711584002872VR5 ITCDx, RC WL AT R BE VERAS 5
05711583037448CAPTIVATE 100 FW 4.0
05711583037431CAPTIVATE 80 FW 4.0
05711583037424CAPTIVATE 60 FW 4.0
05711583037417SOUNDLINK 2 1.10 IOS
05711583037400SOUNDLINK 2 1.10 ANDROID
05711583035994CV100 MNR T R, 2.4G NFM BL DEMO CAPTIVATE 100
05711583035987CV100 MNR T, 2.4G NFM BL DEMO CAPTIVATE 100
05711583035970CV100 B 105, 2.4G NFM BL DEMO CAPTIVATE 100
05711583035932CV60 MNR T R, 2.4G NFM BL DEMO CAPTIVATE 60
05711583035925CV80 MNR T R, 2.4G NFM BL DEMO CAPTIVATE 80
05711583035833CV60 MNR T, 2.4G NFM BL DEMO CAPTIVATE 60
05711583035826CV80 MNR T, 2.4G NFM BL DEMO CAPTIVATE 80
05711583035819CV60 MNR, 2.4G NFM BL DEMO CAPTIVATE 60
05711583035802CV80 MNR, 2.4G NFM BL DEMO CAPTIVATE 80
05711583035796CV100 MNR, 2.4G NFM BL DEMO CAPTIVATE 100
05711583035741CV60 B 105, 2.4G NFM BL DEMO CAPTIVATE 60
05711583035734CV80 B 105, 2.4G NFM BL DEMO CAPTIVATE 80
05711583034225CV60 MNR T R, 2.4G NFM DPB BL CAPTIVATE 60
05711583034218CV60 MNR T R, 2.4G NFM DPB DG CAPTIVATE 60
05711583034201CV60 MNR T R, 2.4G NFM DPB GR CAPTIVATE 60
05711583034195CV60 MNR T R, 2.4G NFM DPB BR CAPTIVATE 60
05711583034188CV60 MNR T R, 2.4G NFM DPB TP CAPTIVATE 60
05711583034171CV60 MNR T R, 2.4G NFM DPB BE CAPTIVATE 60
05711583034164CV60 MNR T, 2.4G NFM DPB BL CAPTIVATE 60
05711583034157CV60 MNR T, 2.4G NFM DPB DG CAPTIVATE 60
05711583034140CV60 MNR T, 2.4G NFM DPB GR CAPTIVATE 60
05711583034133CV60 MNR T, 2.4G NFM DPB BR CAPTIVATE 60
05711583034126CV60 MNR T, 2.4G NFM DPB TP CAPTIVATE 60
05711583034119CV60 MNR T, 2.4G NFM DPB BE CAPTIVATE 60
05711583034102CV60 MNR, 2.4G NFM PB BL CAPTIVATE 60
05711583034096CV60 MNR, 2.4G NFM PB DG CAPTIVATE 60
05711583034089CV60 MNR, 2.4G NFM PB GR CAPTIVATE 60
05711583034072CV60 MNR, 2.4G NFM PB BR CAPTIVATE 60

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