Baha® Fitting Software 5 P1457850

GUDID 09321502044097

N/A

Cochlear Bone Anchored Solutions AB

Hearing aid wireless-fitting computer-aided set Hearing aid wireless-fitting computer-aided set Hearing aid wireless-fitting computer-aided set Hearing aid wireless-fitting computer-aided set Hearing aid wireless-fitting computer-aided set Hearing aid wireless-fitting computer-aided set Hearing aid wireless-fitting computer-aided set Hearing aid wireless-fitting computer-aided set

• Primary Device ID: 09321502044097
• NIH Device Record Key: 96b2dc53-4e92-4cee-a104-b0a37e69a616
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Baha® Fitting Software 5
• Version Model Number: P1457850
• Catalog Number: P1457850
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502044097 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161123

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: 3
• Public Version Date: 2021-09-14
• Device Publish Date: 2018-10-19

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