Baha 95478

GUDID 09321502034654

Baha 5 Power Battery door

Cochlear Bone Anchored Solutions AB

Bone-conduction hearing implant system sound processor/vibrator

• Primary Device ID: 09321502034654
• NIH Device Record Key: 7dd918e1-f880-4ab7-86dc-ace683747f21
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baha
• Version Model Number: 95478
• Catalog Number: 95478
• 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: 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: +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
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502034654 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110996

FDA Product Code

• LXB: Hearing aid, bone conduction

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-11-29
• Device Publish Date: 2017-07-03

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• 09321502035705: BP100 & Baha 4 Tamperproof battery door Peony Pink
• 09321502034067: Colour Cover, Maize (3 pcs)
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• 09321502033428: Colour cover, Copper (3 pcs)
• 09321502033411: Colour cover, Silver (3 pcs)
• 09321502033404: Colour cover, Brown (3 pcs)
• 09321502033398: Colour cover, Blonde (3 pcs)
• 09321502033275: Baha Programming cable CS44 long red
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• 09321502033183: Baha Softband bilateral, Red
• 09321502033176: Baha Softband bilateral, Blonde
• 09321502033169: Baha Softband bilateral, Black
• 09321502033152: Baha Softband bilateral, Brown
• 09321502033145: Baha Softband bilateral, Dark blue
• 09321502033138: Baha Softband bilateral, Light blue
• 09321502033121: Baha Softband bilateral, Pink
• 09321502033114: Baha Softband unilateral, Jungle
• 09321502033107: Baha Softband unilateral, Red
• 09321502033091: Baha Softband unilateral, Blonde
• 09321502033084: Baha Softband unilateral, Black
• 09321502033077: Baha Softband unilateral, Brown