Cochlear Baha SoundBand unilateral, Red

GUDID 09321502078450

Cochlear Bone Anchored Solutions AB

Bone-conduction hearing implant system sound processor/vibrator

• Primary Device ID: 09321502078450
• NIH Device Record Key: fa2621ba-33f2-4370-90c6-c86d1d05f10d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear Baha SoundBand unilateral, Red
• Version Model Number: P1827028
• Company DUNS: 559784736
• Company Name: Cochlear Bone Anchored Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502078450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250215

FDA Product Code

• LXB: Hearing aid, bone conduction

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: 2025-06-13
• Device Publish Date: 2025-06-05

Devices Manufactured by Cochlear Bone Anchored Solutions AB

• 09321502040105 - Baha: 2025-07-15 Fixture mount short Unigrip
• 09321502020664 - Baha: 2025-06-20 Fixture mount standard Unigrip
• 09321502074704 - Baha 7 Sound Processor, Blonde: 2025-06-13
• 09321502074711 - Baha 7 Sound Processor, Black: 2025-06-13
• 09321502074728 - Baha 7 Sound Processor, Silver: 2025-06-13
• 09321502074735 - Baha 7 Sound Processor, Brown: 2025-06-13
• 09321502074742 - Baha 7 Sound Processor, Copper: 2025-06-13
• 09321502074759 - Baha 7 Sound Processor, Mint: 2025-06-13