AccessGUDID - DEVICE: Nucleus (09321502023443)

GUDID

Device Identifier (DI) Information

Brand Name: Nucleus
Version or Model: Z285984
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z285984
Company Name: COCHLEAR LIMITED

Primary DI Number: 09321502023443
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 750551194 *Terms of Use

Device Description: Cochlear Nucleus CP900 Series Standard Rechargeable Battery Module (Smoke)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34158	Secondary battery	A rechargeable set of electrochemical cells, or a single cell, designed to store chemical energy and release it in the form of electrical energy to provide power for active implantable medical devices or external medical instruments, for backup power for programmable devices that must retain electronic information, or to power portable or other medical devices when it is not possible or convenient to use the line supply. The size, shape, and chemical composition of the battery should be specified according to the requirements of the appropriate IEC standard.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MCM	IMPLANT, COCHLEAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P970051	112

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
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

Public Device Record Key: 92275db4-2ce8-4515-aaa9-21dc5eec7896
Public Version Date: February 18, 2025
Public Version Number: 5
DI Record Publish Date: 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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)523-5798
Email: customer@cochlear.com

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