Nucleus Z319071

GUDID 09321502024068

Cochlear EAC200 Series Power Speaker Unit (Size 2, Left)

COCHLEAR LIMITED

Cochlear implant/auditory brainstem implant peripheral connector

• Primary Device ID: 09321502024068
• NIH Device Record Key: 456fcc91-2d25-46c6-8480-c2d8404e35df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nucleus
• Version Model Number: Z319071
• Catalog Number: Z319071
• 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: false
• 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
• Phone: +1(800)523-5798
• Email: customer@cochlear.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	09321502024068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130016

FDA Product Code

• PGQ: Hybrid cochlear implant

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-08
• Device Publish Date: 2014-09-24

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• 09321502022651: Cochlear Nucleus Aqua Accessory (15)
• 09321502022644: Cochlear Nucleus Aqua Accessory (5)
• 09321502032322: Cochlear EAC200 Series Screwdriver
• 09321502022583: Cochlear Nucleus CR200 Series Charging Kit
• 09321502022446: Cochlear Nucleus Battery Charger (Black)
• 09321502022439: Cochlear Nucleus Battery Charging Kit (Black)
• 09321502018128: Cochlear Nucleus CR100 Series Remote Assistant Charging Kit
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• 09321502017688: Cochlear Nucleus CP800 Series Sound Processor Battery Charger (White)
• 09321502013598: FREEDOM 12V CAR ADAPTOR
• 09321502013581: FREEDOM BTE RECHARGER POWER SUPPLY
• 09321502013574: FREEDOM BTE RECHARGER
• 09321502013499: FREEDOM INTERNATIONAL ADAPTOR PLATES (PLUG PACK)
• 09321502024679: Cochlear Nucleus Lapel Microphone (150 cm)
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• 09321502013246: FREEDOM LAPEL MICROPHONE (LAP1)
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• 09321502026673: NUCLEUS SERIES, LOOP BOOSTER
• 09321502022569: CR220 Intraoperative Remote Assistant
• 09321502022552: Cochlear Nucleus CR230 Remote Assistant
• 09321502022545: Cochlear Nucleus CR210 Remote Control
• 09321502022385: Cochlear Nucleus CR120 Intraoperative Remote Assistant
• 09321502022378: Cochlear Nucleus CR100 Series Remote Assistant (White)
• 09321502018104: Cochlear Nucleus CR100 Series Remote Assistant (White)
• 09321502009584: Cochlear Nucleus Freedom Programming POD
• 09321502032612: Cochlear Nucleus® CI532 cochlear implant with Slim Modiolar electrode
• 09321502032599: Cochlear Nucleus® CI522 cochlear implant with Slim Straight electrode
• 09321502030489: CAM CP920 DEMO SP
• 09321502030427: NUCLEUS PROCESSOR CARE KIT - CAM
• 09321502020268: Cochlear Nucleus CI422 cochlear implant with Slim Straight Electrode
• 09321502014564: Cochlear Nucleus CI512 cochlear implant with Contour Advance electrode
• 09321502012089: Cochlear Nucleus Hybrid L24 cochlear implant
• 09321502008891: Cochlear Nucleus Freedom Implant with Straight Electrode
• 09321502007320: Cochlear Nucleus Freedom Implant with Contour Advance Electrode
• 09321502003216: CI 11 11 2M
• 09321502002349: COCHLEAR IMPLANT,CI24R (CS)
• 09321502002318: COCHLEAR IMPLANT, MODEL CI24M
• 09321502041089: Cochlear Coil Spacer
• 09321502033367: AQUA+ N22 6M COIL 8CM
• 09321502033350: AQUA+ N22 6M COIL 6CM
• 09321502033343: AQUA+ N22 COIL 8CM
• 09321502033336: AQUA+ N22 COIL 6CM
• 09321502033312: Aqua + 6M Coil 6cm
• 09321502033305: Aqua + 6M Coil 8cm
• 09321502032759: CP900 SERIES N22 COIL INTEGRATED 6M (WHITE)
• 09321502032742: CP900 SERIES N22 COIL INTEGRATED 6M (SMOKE)
• 09321502032735: CP900 SERIES N22 COIL INTEGRATED 6M (MOCHA)