FDA.reportPublic FDA data

AIM™ Sound Tubes

Primary DI
07630016878237
Brand
AIM™ Sound Tubes
Company
Advanced Bionics AG
Model
CI-6121
Published
2020-04-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
P960058145

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960058145CLARION MULTI-STRATEGY COCHLEAR IMPLANTAdvanced Bionics1997-06-26MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630016878237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630016878237076300168782377630016878237

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant system sound processor speakerA small device designed to be attached to a cochlear implant system sound processor and extended into the external ear canal to function as a speaker providing amplified acoustic low frequency sound to the eardrum, as a conjunct to the electrical input to the implant. It is intended for patients with improvable low frequency hearing and is typically made of synthetic polymer materials with metallic components. This is a single-patient, reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
485262658
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630016880575Slim HP Color Cap CI-7131-0012021-02-08
07630016880582Slim HP Color Cap CI-7131-0022021-02-08
07630016880599Slim HP Color Cap CI-7131-0032021-02-11
07630016880605Slim HP Color Cap CI-7131-0042021-02-11
07630016880612Slim HP Color Cap CI-7131-0052021-02-11
07630016880629Slim HP Color Cap CI-7131-0062021-02-11
07630016880636Slim HP Color Cap CI-7131-0072021-02-11
07630016880650Slim HP Color Cap CI-7131-0092021-02-11
07630016880667Slim HP Color Cap CI-7131-0102021-02-11
07630016880674Slim HP Color Cap CI-7132-0012021-02-11
07630016880681Slim HP Color Cap CI-7132-0022021-02-12
07630016880698Slim HP Color Cap CI-7132-0032021-02-12
07630016880704Slim HP Color Cap CI-7132-0042021-02-12
07630016880919Slim HP Color Cap CI-7131-0112021-02-11
07630016881718Slim HP Color Cap CI-7132-0052021-02-12
07630016871801UHP 3DCI-53162019-08-05
07630016871825AquaMic™3D CI-53172019-08-15
07630016873959UHP 3D PlusCI-53182019-08-07
07630016878404AB Remote CI-6058-0012021-02-12
07630016880186Slim HP AquaMic™CI-5321-0092021-02-12

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09008737461485SONNET Battery Pack Cover Micro Pro, AnthraciteMed-El Elektromedizinische Geräte Gesellschaft m.b.H.MCM2026-02-26
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