Nucleus® 7 Aqua+ Z544583

GUDID 09321502036214

The Nucleus 7 Sound Processor with Aqua+ is water resistant to level IP68 of the International Standard IEC60529. This water protection means that the sound processor with the Aqua+ can be continuously submerged under water to a depth of 3 meters (9 ft and 9 in) for up to 2 hours. This water protection only applies when you use a Cochlear Standard Rechargeable Battery Module.

COCHLEAR LIMITED

Cochlear implant system waterproof kit
Primary Device ID09321502036214
NIH Device Record Key68345445-2ef5-4e44-a1fa-065148d3eaa4
Commercial Distribution StatusIn Commercial Distribution
Brand NameNucleus® 7 Aqua+
Version Model NumberZ544583
Catalog NumberZ544583
Company DUNS750551194
Company NameCOCHLEAR LIMITED
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com
Phone+1(800)523-5798
Emailcustomer@cochlear.com

Device Identifiers

Device Issuing AgencyDevice ID
GS109321502036214 [Primary]
GS109321502041638 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMIMPLANT, COCHLEAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-12
Device Publish Date2017-06-28

Devices Manufactured by COCHLEAR LIMITED

09321502014557 - Cochlear Surgical Instrument Upgrade Kit2024-11-15
09321502009218 - Nucleus2023-11-21 Cochlear Nucleus AOS Forceps for the Contour Advance Electrode
09321502036788 - Nucleus2023-11-03 Nucleus Smart App, (iOS)
09321502043205 - Nucleus2023-11-03 Custom Sound Suite 5.1 CD
09321502043212 - Nucleus2023-11-03 Custom Sound Suite 5.1 Download
09321502043236 - Nucleus2023-11-03 Nucleus Smart App
09321502044899 - Cochlear2023-11-03 Osia™ Fitting Software 2
09321502044905 - Cochlear2023-11-03 Osia™ Fitting Software 2

Trademark Results [Nucleus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NUCLEUS
NUCLEUS
98858455 not registered Live/Pending
b.next, Inc.
2024-11-18
NUCLEUS
NUCLEUS
98858454 not registered Live/Pending
b.next, Inc.
2024-11-18
NUCLEUS
NUCLEUS
98858453 not registered Live/Pending
b.next, Inc.
2024-11-18
NUCLEUS
NUCLEUS
98858452 not registered Live/Pending
b.next, Inc.
2024-11-18
NUCLEUS
NUCLEUS
98858448 not registered Live/Pending
b.next, Inc.
2024-11-18
NUCLEUS
NUCLEUS
98586140 not registered Live/Pending
Good Sportsman Marketing, L.L.C.
2024-06-05
NUCLEUS
NUCLEUS
98571326 not registered Live/Pending
Nucleus AI, LLC
2024-05-28
NUCLEUS
NUCLEUS
98520415 not registered Live/Pending
Nucleus AI, LLC
2024-04-26
NUCLEUS
NUCLEUS
98287985 not registered Live/Pending
NUCLEUS COFFEE TOOLS PTY LTD
2023-11-28
NUCLEUS
NUCLEUS
98117216 not registered Live/Pending
Nucleus Healthcare, LLC
2023-08-04
NUCLEUS
NUCLEUS
98054826 not registered Live/Pending
MAXSIP HC LLC
2023-06-22
NUCLEUS
NUCLEUS
98054775 not registered Live/Pending
MAXSIP HC LLC
2023-06-22

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