Osia® 2 Aqua+ P1302699

GUDID 09321502044967

Case that protects a Osia 2 sound processor from water and particulates

COCHLEAR LIMITED

Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit Cochlear implant system waterproof kit

• Primary Device ID: 09321502044967
• NIH Device Record Key: 5d0fbb8f-8ced-48ff-a97b-52b992b24db0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Osia® 2 Aqua+
• Version Model Number: Osia 2 System
• Catalog Number: P1302699
• Company DUNS: 750551194
• Company Name: COCHLEAR LIMITED
• 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
• 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
• 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	09321502044967 [Primary]
GS1	09321502058544 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191921

FDA Product Code

• PFO: Active implantable bone conduction hearing system

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: 2020-09-14
• Device Publish Date: 2020-09-05

Devices Manufactured by COCHLEAR LIMITED

• 09321502009218 - Nucleus: 2023-11-21 Cochlear Nucleus AOS Forceps for the Contour Advance Electrode
• 09321502036788 - Nucleus: 2023-11-03 Nucleus Smart App, (iOS)
• 09321502043205 - Nucleus: 2023-11-03 Custom Sound Suite 5.1 CD
• 09321502043212 - Nucleus: 2023-11-03 Custom Sound Suite 5.1 Download
• 09321502043236 - Nucleus: 2023-11-03 Nucleus Smart App
• 09321502044899 - Cochlear: 2023-11-03 Osia™ Fitting Software 2
• 09321502044905 - Cochlear: 2023-11-03 Osia™ Fitting Software 2
• 09321502046138 - Cochlear: 2023-11-03 Osia Smart App (iOS)