Baha 5 Sound Processor Tamper-proof battery door 3 pcs P1129017

GUDID 09321502041096

N/A

COCHLEAR LIMITED

Bone-conduction hearing implant system sound processor/vibrator

• Primary Device ID: 09321502041096
• NIH Device Record Key: d707ffaf-a0af-4186-9048-4343ad755508
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baha 5 Sound Processor Tamper-proof battery door 3 pcs
• Version Model Number: P1129017
• Catalog Number: P1129017
• Company DUNS: 750551194
• Company Name: COCHLEAR LIMITED
• Device Count: 3
• 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	09321502041096 [Primary]
GS1	09321502041102 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142907

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: 5
• Public Version Date: 2023-07-28
• Device Publish Date: 2017-06-23

Devices Manufactured by COCHLEAR LIMITED

• 09321502002776 - Nucleus: 2025-03-07 CI24RE Series Non-Magnetic Plug
• 09321502002790 - Nucleus: 2025-03-07 Cochlear Nucleus Depth Gauge (Straight)
• 09321502013369 - Nucleus: 2025-03-07 Cochlear Nucleus CI500 Series Non-Sterile Silicone Implant Template
• 09321502018395 - Nucleus: 2025-03-07 CI500 Series Non-Magnetic Plug
• 09321502024655 - Nucleus: 2025-03-07 Cochlear Nucleus LiteWear Case
• 09321502046152 - Cochlear: 2025-03-07 Cochlear Osia OSI200 Implant
• 09321502026895 - Nucleus: 2025-02-18 NUCLEUS AQUA COIL, 6CM
• 09321502014557 - Cochlear Surgical Instrument Upgrade Kit: 2024-11-15