Bernafon

GUDID 05714464131914

BERNAFON OASISNXT 2024.1

Sbo Hearing A/S

Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software

• Primary Device ID: 05714464131914
• NIH Device Record Key: bc3ca825-81da-4cc0-b43b-f77f4d768a51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bernafon
• Version Model Number: 268336
• Company DUNS: 306018410
• Company Name: Sbo Hearing A/S
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4539177100
• Email: loek@demant.com
• Phone: +4539177100
• Email: loek@demant.com
• Phone: +4539177100
• Email: loek@demant.com
• Phone: +4539177100
• Email: loek@demant.com
• Phone: +4539177100
• Email: loek@demant.com
• Phone: +4539177100
• Email: loek@demant.com
• Phone: +4539177100
• Email: loek@demant.com
• Phone: +4539177100
• Email: loek@demant.com
• Phone: +4539177100
• Email: loek@demant.com
• Phone: +4539177100
• Email: loek@demant.com
• Phone: +4539177100
• Email: loek@demant.com
• Phone: +4539177100
• Email: loek@demant.com
• Phone: +4539177100
• Email: loek@demant.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05714464131914 [Primary]

FDA Product Code

• OSM: Hearing Aid, Air-Conduction with Wireless Technology, Prescription

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: 2024-02-16
• Device Publish Date: 2024-02-08

On-Brand Devices [Bernafon]

• 05707131265593: TVA2, BERNAFON DG TV ADAPTER 2
• 05714464004546: OASISNXT CUSTOM 2020.2
• 05714464004539: BERNAFON OASISNXT 2020.2
• 05714464004522: OASISNXT CUSTOM 2020.2 COSTCO
• 05714464011421: ALIGO 5 FW 1.0.0
• 05714464011414: ALIGO 7 FW 1.0.0
• 05714464011407: ALIGO 9 FW 1.0.0
• 05714464011360: ALPHA 5 FW 1.0.0
• 05714464011353: ALPHA 7 FW 1.0.0
• 05714464011346: ALPHA 9 FW 1.0.0
• 05714464011261: EASYCONTROL-A 2.3.0 IOS
• 05714464011254: EASYCONTROL-A 2.3.0 ANDROID
• 05714464004584: BERNAFON EASYCONTROL CONNECT 3.1.0 IOS
• 05714464004577: BERNAFON EASYCONTROL CONNECT 3.1.0 ANDROID
• 05711584121559: CHARGER, MINIRITE T R BL NEUTRAL
• 05714464012046: EASYCONTROL-A 2.4.0 ANDROID
• 05714464012039: EASYCONTROL-A 2.4.0 IOS
• 05714464013036: Bernafon OasisNxt 2021.2
• 05714464012992: Bernafon EasyControl Connect 3.3.0 iOS
• 05714464012985: Bernafon EasyControl Connect 3.3.0 Android
• 05714464033133: Alpha 5 FW 1.1.0
• 05714464033126: Alpha 7 FW 1.1.0
• 05714464033119: Alpha 9 FW 1.1.0
• 05714464031955: AO5 MNR T MAC ALIGO 5
• 05714464031948: AO5 MNR T MSIL ALIGO 5
• 05714464031931: AO5 MNR T SABE/MSIL ALIGO 5
• 05714464031924: AO5 MNR T SABE/MAC ALIGO 5
• 05714464031436: AO7 MNR T MAC ALIGO 7
• 05714464031429: AO7 MNR T MSIL ALIGO 7
• 05714464031412: AO7 MNR T SABE/MSIL ALIGO 7
• 05714464031405: AO7 MNR T SABE/MAC ALIGO 7
• 05714464030910: AO9 MNR T MAC ALIGO 9
• 05714464030903: AO9 MNR T MSIL ALIGO 9
• 05714464030897: AO9 MNR T SABE/MSIL ALIGO 9
• 05714464030880: AO9 MNR T SABE/MAC ALIGO 9
• 05714464028900: AO5 MNR T SABE/MAC ALIGO 5 DEMO
• 05714464028894: AO7 MNR T SABE/MAC ALIGO 7 DEMO
• 05714464028887: AO9 MNR T SABE/MAC ALIGO 9 DEMO
• 05714464012855: EASYCONTROL-A 2.5.0 IOS
• 05714464012848: EASYCONTROL-A 2.5.0 ANDROID
• 05714464052400: ALPHA 1 FW, 1.3.0
• 05714464052394: ALPHA 3 FW 1.3.0
• 05714464052387: ALPHA 5 FW 1.3.0
• 05714464052370: ALPHA 7 FW 1.3.0
• 05714464052363: ALPHA 9 FW 1.3.0
• 05714464042975: BERNAFON, CHARGER MNB T R DEMO
• 05714464034680: Bernafon Oasisnxt 2022.1.0
• 05714464034611: Bernafon EasyControl Connect 3.4.0 iOS
• 05714464034604: Bernafon EasyControl Connect 3.4.0 Android
• 05714464032839: BERNAFON, CHARGER PLUS MNB T R