FDA.reportPublic FDA data

Sky CI™ M90

Primary DI
00197420012581
Brand
Sky CI™ M90
Company
Advanced Bionics Corporation
Model
CI-5295
Device description
(blue ocean)
Published
2024-12-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

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
P960058149

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960058149CLARION MULTI-STRATEGY COCHLEAR IMPLANTAdvanced Bionics1997-06-26MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00197420012581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197420012581001974200125811974200125810197420012581

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant/auditory brainstem implant sound processorAn external component of a cochlear implant (CI) or auditory brainstem implant system that typically consists of a battery-powered microphone/transmitter (transducer) designed to convert sound waves from the environment into electrical signals which are transmitted to the implantable portion of the system, via a coil (which may or may not be included), for the partial restoration of auditory sensation in a severely/profoundly deaf person. Also known as a speech processor, it is typically worn like a behind-the-ear (BTE) or off-the-ear (OTE) hearing aid.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(661)362-1400xxx@xxx.xxx

Regulatory Flags#

DUNS number
828340674
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197420012543Sky CI™ M90CI-52952024-12-16
00197420012567Sky CI™ M90CI-52952024-12-16
00197420012604Sky CI™ M90CI-52952024-12-16
00197420012628Sky CI™ M90CI-52952024-12-16
00197420012642Sky CI™ M90CI-52952024-12-16
00197420012666Sky CI™ M90CI-52952024-12-16
00197420012680Sky CI™ M90CI-52952024-12-16
00197420012703Sky CI™ M90CI-52952024-12-16
00197420012727Sky CI™ M90CI-52952024-12-16
00197420012741Sky CI™ M90CI-52952024-12-16
00197420012765Sky CI™ M90CI-52952024-12-16
00197420012789Sky CI™ M90CI-52952024-12-16
00197420012802Sky CI™ M90CI-52952024-12-16
00197420012826Sky CI™ M90CI-52952024-12-16
00197420012840Sky CI™ M90CI-52952024-12-16
00197420012864Sky CI™ M90CI-52952024-12-16
00197420012888Sky CI™ M90CI-52952024-12-16
00197420012901Sky CI™ M90CI-52952024-12-16
00197420012925Sky CI™ M90CI-52952024-12-16
00197420012949Sky CI™ M90CI-52952024-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00197420012543Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012567Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
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
00197420012703Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012727Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012741Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012765Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012789Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012802Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012826Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012840Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012864Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012888Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012901Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012925Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012949Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012963Sky CI™ M90Advanced Bionics CorporationMCM2024-12-16
00197420012987Naida™ CI M90Advanced Bionics CorporationMCM2024-12-16
00197420013007Naida™ CI M90Advanced Bionics CorporationMCM2024-12-16
00197420013021Naida™ CI M90Advanced Bionics CorporationMCM2024-12-16