FDA.reportPublic FDA data

Slim HP AquaMic™

Primary DI
00840094446243
Brand
Slim HP AquaMic™
Company
Advanced Bionics, LLC
Model
CI-5321-005
Device description
"18"" Beige"
Published
2023-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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
07630016880179PreviousGS10
00840094446243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
07630016880179076300168801797630016880179
00840094446243008400944462438400944462430840094446243

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant/auditory brainstem implant external coilAn external component of a cochlear implant (CI) or auditory brainstem implant system designed to transmit the electrical signals generated by the sound processor to the implantable receiver-stimulator and electrode array assembly (none included) of the hearing implant for the partial restoration of auditory sensation in a severely/profoundly deaf person. It is typically a round-shaped device with a magnet in its centre to magnetically couple with the implantable receiver-stimulator.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length46Centimeter

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
803906382
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630016809606Electrode Insertion ToolMMT-61112015-10-08
07630016809927Electrode Claw ToolCI-42522015-10-14
07630016809934Recess Gauge for HiRes 90K™CI-43302015-10-08
07630016809941Coil Gauge for HiRes 90K™CI-43402015-10-08
07630016809958Helix Cochleostomy Sizing GaugeCI-43452015-10-14
07630016809965BTE-ICS Template for HiRes 90KCI-44202015-10-08
07630016809989Recess Marking Template for HiRes 90K™CI-44302015-10-08
00840094404717RF CableCI-5415-3032023-01-13
00840094404731RF CableCI-5415-3052023-01-13
00840094404748RF CableCI-5415-3012023-01-13
00840094404755RF CableCI-5415-3022023-01-13
00840094404779RF CableCI-5415-5042023-01-13
00840094404809RF CableCI-5415-5022023-01-13
00840094404878RF CableCI-5415-5042023-01-13
00840094405424UHP 3D Color CapCI-7129-3202023-01-13
00840094405431UHP 3D Color CapCI-7129-3302023-01-13
00840094405448UHP 3D Color CapCI-7129-3402023-01-13
00840094405455UHP 3D Color CapCI-7129-3502023-01-13
00840094405462UHP 3D Color CapCI-7129-3602022-12-09
00840094405479UHP 3D Color CapCI-7129-3702022-12-09

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
00197420012581Sky 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