Cochlear™ Nucleus® 8 Processing Unit P1840542

GUDID 09321502065221

CP1110 Processing Unit, Grey

COCHLEAR LIMITED

Cochlear implant/auditory brainstem implant sound processor

• Primary Device ID: 09321502065221
• NIH Device Record Key: 1da06105-3275-4fe8-a5c7-954ffa029aa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cochlear™ Nucleus® 8 Processing Unit
• Version Model Number: P1840542
• Catalog Number: P1840542
• Company DUNS: 750551194
• Company Name: COCHLEAR LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502065221 [Primary]

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: 2022-12-07
• Device Publish Date: 2022-11-29

On-Brand Devices [Cochlear™ Nucleus® 8 Processing Unit]

• 09321502065245: CP1110 Processing Unit, Silver
• 09321502065238: CP1110 Processing Unit, White
• 09321502065221: CP1110 Processing Unit, Grey
• 09321502065214: CP1110 Processing Unit, Sand
• 09321502065207: CP1110 Processing Unit, Brown
• 09321502065191: CP1110 Processing Unit, Black