DEVICE: Nucleus (09321502024785)
Device Identifier (DI) Information
Nucleus
Z407007
In Commercial Distribution
Z407007
COCHLEAR LIMITED
Z407007
In Commercial Distribution
Z407007
COCHLEAR LIMITED
Cochlear Nucleus CP800 Series Compact Rechargeable Battery Module (Brown) CAM
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36534 | Portable/mobile rechargeable battery pack |
A group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MCM | IMPLANT, COCHLEAR |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
P970051 | 053 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between -10 and 55 Degrees Celsius |
Storage Environment Temperature: between -10 and 55 Degrees Celsius |
Handling Environment Humidity: between 0 and 90 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
255d4b10-9309-4991-bfdd-0635f1ad4aed
May 03, 2023
5
September 24, 2014
May 03, 2023
5
September 24, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)523-5798
customer@cochlear.com
customer@cochlear.com