FDA.reportPublic FDA data

Cochlear

Primary DI
09321502044899
Brand
Cochlear
Company
COCHLEAR LIMITED
Model
P1341442
Catalog number
P1341442
Device description
Osia™ Fitting Software 2
Published
2019-11-23
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
PFOActive implantable bone conduction hearing system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFOActive Implantable Bone Conduction Hearing SystemEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191921000Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsCochlear Americas2019-11-15PFO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09321502044899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09321502044899093215020448999321502044899

GMDN Terms#

Term, Definition table
TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or evaluate and adjust the settings of a hearing assistive device. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and intended to be used on a non-medical computerized device (e.g., smartphone, tablet).

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
750551194
Device count
1
Manufacturing date on label
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
05712149025459SentioOticon Medical ABPFO2024-07-22
05712149025466SentioOticon Medical ABPFO2024-07-22
05712149025473SentioOticon Medical ABPFO2024-07-22
05712149025480SentioOticon Medical ABPFO2024-07-22
05712149025497SentioOticon Medical ABPFO2024-07-22
05712149025503SentioOticon Medical ABPFO2024-07-22
05712149026906SentioOticon Medical ABPFO2024-07-22
09321502074131OSIA FITTING SOFTWARE 2 CDCochlear Americas CorporationPFO2024-01-03
09321502070409Osia 2(I) Sound Processor kitCOCHLEAR LIMITEDPFO2023-09-15
09321502070676Osia OSI300 ImplantCOCHLEAR LIMITEDPFO2023-09-15
09321502070683Cochlear™ Magnet CassetteCOCHLEAR LIMITEDPFO2023-09-15
09321502070959Osia 2(I) SP Magnet strength 1(I)COCHLEAR LIMITEDPFO2023-09-15
09321502070966Osia 2 (I) SP Magnet strength 2(I)COCHLEAR LIMITEDPFO2023-09-15
09321502070973Osia 2(I) SP Magnet strength 3(I)COCHLEAR LIMITEDPFO2023-09-15
09321502070980Osia 2(I) SP Magnet strength 4(I)COCHLEAR LIMITEDPFO2023-09-15
09321502070997Osia 2(I) SP Magnet (I) ToolCOCHLEAR LIMITEDPFO2023-09-15
09008737525323SAMBA 2 BB PoM, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2023-07-05
09008737525330SAMBA 2 BB PoM, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2023-07-05
09008737532925SAMBA 2 GO w/o manualsMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2022-11-16
09321502065924Cochlear™ MRI KitCOCHLEAR LIMITEDPFO2022-08-10
09321502046527Cochlear™ Sterile Non-Magnetic PlugCOCHLEAR LIMITEDPFO2021-03-09
09321502046534Cochlear™ Sterile Replacement MagnetCOCHLEAR LIMITEDPFO2021-03-09
09008737520472SAMBA 2 Remote (Android)Med-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525033SYMFIT 8.0 DownloadMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525071SAMBA 2 GOMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525262SAMBA 2 BB AP Unit, rightMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525279SAMBA 2 BB AP Unit, leftMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525811SYMFIT 8.0 DVDMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737525859SYMFIT 8.0 USBMed-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08
09008737526030SAMBA 2 Remote (iOS)Med-El Elektromedizinische Geräte Gesellschaft m.b.H.PFO2020-09-08