FDA.reportPublic FDA data

Nucleus

Primary DI
09321502024785
Brand
Nucleus
Company
COCHLEAR LIMITED
Model
Z407007
Catalog number
Z407007
Device description
Cochlear Nucleus CP800 Series Compact Rechargeable Battery Module (Brown) CAM
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
P970051053

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970051053NUCLEUS 24 COCHLEAR IMPLANT SYSTEMCochlear Americas1998-06-25MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502024785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502024785093215020247859321502024785

GMDN Terms#

Term, Definition table
TermDefinition
Rechargeable battery packA 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 is typically used during a transport situation (e.g., a neonatal incubator) or when it is designed to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius55 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
750551194
Device count
1
Lot or batch
true
Manufacturing date on label
true
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

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Primary DI, Brand, Company table
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