Nucleus
- Primary DI
- 09321502024006
- Brand
- Nucleus
- Company
- COCHLEAR LIMITED
- Model
- Z319065
- Catalog number
- Z319065
- Device description
- Cochlear EAC200 Series Power Speaker Unit (Size 1, Right)
- Published
- 2014-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
cochlear.comProduct Codes#
| Code | Name |
|---|---|
| PGQ | Hybrid cochlear implant |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| PGQ | Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification | Unknown | 3 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| P130016 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 09321502024006 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 09321502024006 | 09321502024006 | 9321502024006 |
GMDN Terms#
| Term | Definition |
|---|---|
| Cochlear implant/auditory brainstem implant peripheral connector | A device designed to be used with a cochlear implant (CI) or auditory brainstem implant system to connect the sound processor to power options (e.g., battery pack) and/or to enable connections to external devices that may be used as peripherals to the implant system; the connected devices are not included. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(800)523-5798 | customer@cochlear.com |
Regulatory Flags#
- DUNS number
- 750551194
- Device count
- 1
- Lot or batch
- true
- No natural rubber latex
- true
Other Devices From This Company#
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|---|---|---|---|---|
| 09321502053082 | Cochlear® Nucleus® Nexa™ cochlear implant with Slim Straight electrode | CI1022 | Z334204 | 2025-07-07 |
| 09321502053099 | Cochlear® Nucleus® Nexa™ cochlear implant with Slim Modiolar electrode | CI1032 | P1434929 | 2025-07-07 |
| 09321502053105 | Cochlear® Nucleus® Nexa™ cochlear implant with Slim 20 electrode | CI1024 | P1549674 | 2025-07-07 |
| 09321502069847 | Cochlear® Nucleus® Nexa™ cochlear implant | CI1012 | P1979576 | 2025-07-07 |
| 09321502014564 | Cochlear® Nucleus® CI512 cochlear Implant | CI512 | Z209051 | 2014-09-24 |
| 09321502032599 | Cochlear® Nucleus® CI522 cochlear Implant with Slim Straight electrode | CI522 | Z382660 | 2016-09-20 |
| 09321502032612 | Cochlear® Nucleus® CI532 cochlear Implant with Slim Modiolar electrode | CI532 | Z285654 | 2016-09-20 |
| 09321502046329 | Cochlear® Nucleus® CI624 cochlear implant with Slim 20 electrode | CI624 | P1431676 | 2020-02-18 |
| 09321502036573 | Cochlear® Nucleus® CI622 cochlear Implant with Slim Straight electrode | CI622 | P783829 | 2019-07-12 |
| 09321502036580 | Cochlear® Nucleus® CI632 cochlear Implant with Slim Modiolar electrode | CI632 | P783831 | 2019-07-12 |
| 09321502036818 | Cochlear® Nucleus® CI612 cochlear Implant | CI612 | P774600 | 2019-07-12 |
| 09321502046459 | Cochlear | P1624218 | P1624218 | 2020-01-03 |
| 09321502046466 | Cochlear | P1624188 | P1624188 | 2020-01-03 |
| 09321502046473 | Cochlear | P1624189 | P1624189 | 2020-01-03 |
| 09321502046480 | Cochlear | P1624190 | P1624190 | 2020-01-03 |
| 09321502046497 | Cochlear | P1624191 | P1624191 | 2020-01-03 |
| 09321502039864 | Nucleus® 7 Processing Unit | CP1000 | Z544559 | 2017-07-07 |
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| 09321502063715 | Cochlear™ Personalisation Cover | P1840591 | P1840591 | 2022-11-30 |
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