Bernafon

GUDID 05711584087114

ZR3, KIT 10 85 PB BE ZERENA 3

Bernafon AG

In-the-ear air-conduction hearing aid

• Primary Device ID: 05711584087114
• NIH Device Record Key: 7cc8cedc-f749-4f66-9332-630b44ed5648
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bernafon
• Version Model Number: 191991
• Company DUNS: 480002286
• Company Name: Bernafon AG
• 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	05711584087114 [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 [Bernafon]

• 05711584106532: CORAL 9 FW 4.0
• 05711584106525: CORAL 7 FW 4.0
• 05711584106518: CORAL 5 FW 4.0
• 05711584106501: VIRON 9 FW 4.0
• 05711584106495: VIRON 7 FW 4.0
• 05711584106488: VIRON 5 FW 4.0
• 05711584095515: EASYCONTROL-A 1.10 IOS
• 05711584095508: EASYCONTROL-A 1.10 ANDROID
• 05711584095492: VN5 MNR T R, 2.4G NFM SABE/MAC DEMO VIRON 5
• 05711584095485: VN7 MNR T R, 2.4G NFM SABE/MAC DEMO VIRON 7
• 05711584095478: VN9 MNR T R, 2.4G NFM SABE/MAC DEMO VIRON 9
• 05711584095461: VN5 MNR T, 2.4G NFM SABE/MAC DEMO VIRON 5
• 05711584095454: VN7 MNR T, 2.4G NFM SABE/MAC DEMO VIRON 7
• 05711584095447: VN9 MNR T, 2.4G NFM SABE/MAC DEMO VIRON 9
• 05711584095430: VN5 MNR, 2.4G NFM SABE/MAC DEMO VIRON 5
• 05711584095423: VN7 MNR, 2.4G NFM SABE/MAC DEMO VIRON 7
• 05711584095416: VN9 MNR, 2.4G NFM SABE/MAC DEMO VIRON 9
• 05711584095409: VN5 B 105, 2.4G NFM SABE/MAC DEMO VIRON 5
• 05711584095393: VN7 B 105, 2.4G NFM SABE/MAC DEMO VIRON 7
• 05711584095386: VN9 B 105, 2.4G NFM SABE/MAC DEMO VIRON 9
• 05711584095171: VN5 MNR T R, 2.4G NFM DPB JEBL VIRON 5
• 05711584095164: VN5 MNR T R, 2.4G NFM DPB MAC/MSIL VIRON 5
• 05711584095157: VN5 MNR T R, 2.4G NFM DPB MAC VIRON 5
• 05711584095140: VN5 MNR T R, 2.4G NFM DPB MSIL VIRON 5
• 05711584095133: VN5 MNR T R, 2.4G NFM DPB MSIL/MAC VIRON 5
• 05711584095126: VN5 MNR T R, 2.4G NFM DPB COBR VIRON 5
• 05711584095119: VN5 MNR T R, 2.4G NFM DPB ANBR VIRON 5
• 05711584095102: VN5 MNR T R, 2.4G NFM DPB SABE/MSIL VIRON 5
• 05711584095096: VN5 MNR T R, 2.4G NFM DPB SABE/MAC VIRON 5
• 05711584095089: VN5 MNR T, 2.4G NFM DPB JEBL VIRON 5
• 05711584095072: VN5 MNR T, 2.4G NFM DPB MAC/MSIL VIRON 5
• 05711584095065: VN5 MNR T, 2.4G NFM DPB MAC VIRON 5
• 05711584095058: VN5 MNR T, 2.4G NFM DPB MSIL VIRON 5
• 05711584095041: VN5 MNR T, 2.4G NFM DPB MSIL/MAC VIRON 5
• 05711584095034: VN5 MNR T, 2.4G NFM DPB COBR VIRON 5
• 05711584095027: VN5 MNR T, 2.4G NFM DPB ANBR VIRON 5
• 05711584095010: VN5 MNR T, 2.4G NFM DPB SABE/MSIL VIRON 5
• 05711584095003: VN5 MNR T, 2.4G NFM DPB SABE/MAC VIRON 5
• 05711584094990: VN5 MNR, 2.4G NFM PB JEBL VIRON 5
• 05711584094983: VN5 MNR, 2.4G NFM PB MAC/MSIL VIRON 5
• 05711584094976: VN5 MNR, 2.4G NFM PB MAC VIRON 5
• 05711584094969: VN5 MNR, 2.4G NFM PB MSIL VIRON 5
• 05711584094952: VN5 MNR, 2.4G NFM PB MSIL/MAC VIRON 5
• 05711584094945: VN5 MNR, 2.4G NFM PB COBR VIRON 5
• 05711584094938: VN5 MNR, 2.4G NFM PB ANBR VIRON 5
• 05711584094921: VN5 MNR, 2.4G NFM PB SABE/MSIL VIRON 5
• 05711584094914: VN5 MNR, 2.4G NFM PB SABE/MAC VIRON 5
• 05711584094907: VN7 MNR T R, 2.4G NFM DPB JEBL VIRON 7
• 05711584094891: VN7 MNR T R, 2.4G NFM DPB MAC/MSIL VIRON 7
• 05711584094884: VN7 MNR T R, 2.4G NFM DPB MAC VIRON 7