Neutral

GUDID 05714464127191

REMOTELINK 2 1.2.0 IOS

Sbo Hearing A/S

Hearing aid/implant system remote control

• Primary Device ID: 05714464127191
• NIH Device Record Key: 587e2ebe-2f0f-4f2a-94c5-cf07abf3b537
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neutral
• Version Model Number: 265710
• 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
• 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	05714464127191 [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: 2023-08-15
• Device Publish Date: 2023-08-07

On-Brand Devices [Neutral]

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• 05714464012091: REMOTELINK 2.4.0 ANDROID
• 05714464013029: OasisNxt Custom 2021.2
• 05714464012916: RemoteFit 3.3.0 iOS
• 05714464012909: RemoteFit 3.3.0 Android
• 05714464012879: RemoteLink Connect 3.3.0 iOS
• 05714464012862: RemoteLink Connect 3.3.0 Android
• 05714464012794: REMOTELINK 2.5.0 IOS
• 05714464012787: REMOTELINK 2.5.0 ANDROID
• 05714464042487: RemoteFit 3.4.0 iOS
• 05714464042470: RemoteFit 3.4.0 Android
• 05714464034697: Oasisnxt Custom 2022.1.0
• 05714464034673: RemoteLink Connect 3.4.0 iOS
• 05714464034666: RemoteLink Connect 3.4.0 Android
• 05714464033829: FW updater App 1.0.0 iOS
• 05714464032846: CHARGER PLUS, MNB T R
• 05714464028641: CHARGER, MNB T R NEUTRAL
• 05714464060306: REMOTEFIT 3.5.0 ANDROID
• 05714464060290: REMOTEFIT 3.5.0 IOS
• 05714464059829: OASISNXT CUSTOM 2022.2
• 05714464059805: REMOTELINK CONNECT 3.5.0 IOS
• 05714464059799: REMOTELINK CONNECT 3.5.0 ANDROID
• 05714464095643: Oasisnxt Custom 2023.1
• 05714464058952: RemoteLink 2 1.0.0 iOS
• 05714464058945: RemoteLink 2 1.0.0 Android
• 05714464125180: REMOTELINK 2 1.1.0 IOS
• 05714464125173: REMOTELINK 2 1.1.0 ANDROID
• 05714464127207: REMOTELINK 2 1.2.0 ANDROID
• 05714464127191: REMOTELINK 2 1.2.0 IOS
• 05714464133949: REMOTELINK 2 1.3.0 IOS
• 05714464133932: REMOTELINK 2 1.3.0 ANDROID
• 05714464131921: OASISNXT CUSTOM 2024.1
• 05714464131105: CHARGER PLUS MNR NEUTRAL
• 05714464131013: CHARGER MNR NEUTRAL
• 05714464139491: REMOTELINK 2 1.4.0 ANDROID
• 05714464139446: REMOTELINK 2 1.4.0 IOS
• 05714464146048: REMOTELINK 2 1.5.0 IOS
• 05714464146031: REMOTELINK 2 1.5.0 ANDROID
• 05714464175406: OASISNXT CUSTOM 2026.1