FDA.reportPublic FDA data

Nucleus

Primary DI
09321502028073
Brand
Nucleus
Company
COCHLEAR LIMITED
Model
Z61034
Catalog number
Z61034
Device description
FREEDOM MINI BTE CONTROLLER BATTERY HOLDER, PINK
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#

Product Codes#

Code, Name table
CodeName
MCMIMPLANT, COCHLEAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCMImplant, CochlearUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970051028

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970051028NUCLEUS 24 COCHLEAR IMPLANT SYSTEMCochlear Americas1998-06-25MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502028073PrimaryGS10
09321502032032Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502028073093215020280739321502028073
09321502032032093215020320329321502032032

GMDN Terms#

Term, Definition table
TermDefinition
Battery boxA special container intended to be used to house batteries for protective purposes. This device will typically be portable so that the user can safely carry the power source.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-5798customer@cochlear.com

Regulatory Flags#

DUNS number
750551194
Device count
2
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09321502053082Cochlear® Nucleus® Nexa™ cochlear implant with Slim Straight electrodeCI1022Z3342042025-07-07
09321502053099Cochlear® Nucleus® Nexa™ cochlear implant with Slim Modiolar electrodeCI1032P14349292025-07-07
09321502053105Cochlear® Nucleus® Nexa™ cochlear implant with Slim 20 electrodeCI1024P15496742025-07-07
09321502069847Cochlear® Nucleus® Nexa™ cochlear implantCI1012P19795762025-07-07
09321502014564Cochlear® Nucleus® CI512 cochlear ImplantCI512Z2090512014-09-24
09321502032599Cochlear® Nucleus® CI522 cochlear Implant with Slim Straight electrodeCI522Z3826602016-09-20
09321502032612Cochlear® Nucleus® CI532 cochlear Implant with Slim Modiolar electrodeCI532Z2856542016-09-20
09321502046329Cochlear® Nucleus® CI624 cochlear implant with Slim 20 electrodeCI624P14316762020-02-18
09321502036573Cochlear® Nucleus® CI622 cochlear Implant with Slim Straight electrodeCI622P7838292019-07-12
09321502036580Cochlear® Nucleus® CI632 cochlear Implant with Slim Modiolar electrodeCI632P7838312019-07-12
09321502036818Cochlear® Nucleus® CI612 cochlear ImplantCI612P7746002019-07-12
09321502046459CochlearP1624218P16242182020-01-03
09321502046466CochlearP1624188P16241882020-01-03
09321502046473CochlearP1624189P16241892020-01-03
09321502046480CochlearP1624190P16241902020-01-03
09321502046497CochlearP1624191P16241912020-01-03
09321502039864Nucleus® 7 Processing UnitCP1000Z5445592017-07-07
09321502063692Cochlear™ Personalisation CoverP1840531P18405312022-11-30
09321502063715Cochlear™ Personalisation CoverP1840591P18405912022-11-30
09321502066815Cochlear™ Microphone CoverP1878176P18781762022-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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09008737461386SONNET Battery Pack Cover Standard Pro, EbonyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461393SONNET Battery Pack Cover Standard Pro, Nordic GrayMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461409SONNET Battery Pack Cover Standard Pro, BeigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461416SONNET Battery Pack Cover Standard Pro, WhiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461423SONNET Battery Pack Cover Standard Pro, BlackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461485SONNET Battery Pack Cover Micro Pro, AnthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461492SONNET Battery Pack Cover Micro Pro, EbonyMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461508SONNET Battery Pack Cover Micro Pro, Nordic GrayMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461515SONNET Battery Pack Cover Micro Pro, BeigeMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461522SONNET Battery Pack Cover Micro Pro, WhiteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09008737461539SONNET Battery Pack Cover Micro Pro, BlackMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
09321502082341Cochlear™ ECochG MeasuresCOCHLEAR LIMITEDMCM2025-10-22
09321502072236Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072243Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072250Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072267Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502072274Cochlear™ Kanso® 3 Microphone CoverCOCHLEAR LIMITEDMCM2025-07-07
09321502053082Cochlear® Nucleus® Nexa™ cochlear implant with Slim Straight electrodeCOCHLEAR LIMITEDMCM2025-07-07
09321502053099Cochlear® Nucleus® Nexa™ cochlear implant with Slim Modiolar electrodeCOCHLEAR LIMITEDMCM2025-07-07
09321502053105Cochlear® Nucleus® Nexa™ cochlear implant with Slim 20 electrodeCOCHLEAR LIMITEDMCM2025-07-07
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00197420012543Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012567Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
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00197420012604Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012628Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012642Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012666Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012680Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16