Sonic

GUDID 05711583030456

ET80, KIT 10 85 BE ENCHANT 80

Sonic Innovations, Inc.

In-the-ear air-conduction hearing aid

• Primary Device ID: 05711583030456
• NIH Device Record Key: 6811ed82-67ae-4895-aeb7-aac17448b449
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonic
• Version Model Number: 186225
• Company DUNS: 968696919
• Company Name: Sonic Innovations, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com
• Phone: +4539177100
• Email: hama@oticon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05711583030456 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133308

FDA Product Code

• KLW: Masker, tinnitus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-20
• Device Publish Date: 2018-08-20

On-Brand Devices [Sonic]

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