Kanso Halo Accessory P1893411

GUDID 09321502066600

COCHLEAR LIMITED

Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder Cochlear implant/auditory brainstem implant sound processor off-ear holder

• Primary Device ID: 09321502066600
• NIH Device Record Key: 0be6a5c3-f24c-4ae5-bf04-f6901418f371
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kanso Halo Accessory
• Version Model Number: P1893411
• Catalog Number: P1893411
• Company DUNS: 750551194
• Company Name: COCHLEAR LIMITED
• Device Count: 2
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502065320 [Primary]
GS1	09321502066600 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P970051

FDA Product Code

• MCM: Implant, cochlear

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: 2022-04-18
• Device Publish Date: 2022-04-08

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)