| Primary Device ID | 09321502028950 | 
| NIH Device Record Key | eb8b9474-8f2b-4b51-8f0f-decec04c87c0 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Nucleus | 
| Version Model Number | S50714 | 
| Catalog Number | S50714 | 
| 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 | false | 
| 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 | 
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | |
| Phone | +1(800)523-5798 | 
| customer@cochlear.com | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Device Size Text, specify | 0 | 
| Length | 50 Centimeter | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius | 
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 09321502028950 [Primary] | 
| MCM | IMPLANT, COCHLEAR | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 4 | 
| Public Version Date | 2022-04-08 | 
| Device Publish Date | 2014-09-24 | 
| 09321502022668 | Cochlear Nucleus Aqua Accessory (30) | 
| 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 | 
| 09321502017794 | Cochlear Nucleus CP800 Series Sound Processor Charging Kit (White) | 
| 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) | 
| 09321502018098 | Cochlear Nucleus CP800 Series Lapel Microphone | 
| 09321502013246 | FREEDOM LAPEL MICROPHONE (LAP1) | 
| 09321502052139 | Nucleus® Sound Processor Kit | 
| 09321502038775 | MRI Splint and Bandage Kit | 
| 09321502027632 | NUCLEUS CR120 INTRAOPERATIVE REMOTE ASSISTANT KIT | 
| 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) | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  NUCLEUS  98858455  not registered Live/Pending | b.next, Inc. 2024-11-18 | 
|  NUCLEUS  98858454  not registered Live/Pending | b.next, Inc. 2024-11-18 | 
|  NUCLEUS  98858453  not registered Live/Pending | b.next, Inc. 2024-11-18 | 
|  NUCLEUS  98858452  not registered Live/Pending | b.next, Inc. 2024-11-18 | 
|  NUCLEUS  98858448  not registered Live/Pending | b.next, Inc. 2024-11-18 | 
|  NUCLEUS  98586140  not registered Live/Pending | Good Sportsman Marketing, L.L.C. 2024-06-05 | 
|  NUCLEUS  98571326  not registered Live/Pending | Nucleus AI, LLC 2024-05-28 | 
|  NUCLEUS  98520415  not registered Live/Pending | Nucleus AI, LLC 2024-04-26 | 
|  NUCLEUS  98287985  not registered Live/Pending | NUCLEUS COFFEE TOOLS PTY LTD 2023-11-28 | 
|  NUCLEUS  98117216  not registered Live/Pending | Nucleus Healthcare, LLC 2023-08-04 | 
|  NUCLEUS  98054826  not registered Live/Pending | MAXSIP HC LLC 2023-06-22 | 
|  NUCLEUS  98054775  not registered Live/Pending | MAXSIP HC LLC 2023-06-22 |