FDA.reportPublic FDA data

Naida CI AquaCase

Primary DI
00840094452725
Brand
Naida CI AquaCase
Company
Advanced Bionics, LLC
Model
CI-7431
Published
2023-01-13
Public version status
New
Distribution status
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
P960058106

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960058106CLARION MULTI-STRATEGY COCHLEAR IMPLANTAdvanced Bionics1997-06-26MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630016835254PreviousGS10
00840094452725PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
07630016835254076300168352547630016835254
00840094452725008400944527258400944527250840094452725

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant system waterproof kitA collection of non-sterile devices intended to be used with a cochlear implant system to protect the externally worn components in wet and/or rugged environments (e.g. for swimming, showering). The set typically consists of a sound processor case, waterproof microphone, and a connecting cable. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
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
00197420015179PowerCel™ 110 MiniCI-5521-1202026-10-26
00197420015186PowerCel™ 110 MiniCI-5521-1302026-10-26
00197420015216PowerCel™ 110 MiniCI-5521-1402026-10-26
00197420015223PowerCel™ 110 MiniCI-5521-1502026-10-26
00197420015254PowerCel™ 110 MiniCI-5521-1602026-10-26
00197420015278PowerCel™ 110 MiniCI-5521-1702026-10-26
00197420015292PowerCel™ 170 MiniCI-5527-2302026-10-26
00197420015315PowerCel™ 170 MiniCI-5527-2402026-10-26
00197420015339PowerCel™ 110CI-5511-1202026-10-26
00197420015353PowerCel™ 110CI-5511-1302026-10-26
00197420015377PowerCel™ 110 MiniCI-5521-2402026-10-26
00197420015407PowerCel™ 170 MiniCI-5527-1202026-10-26
00197420015421PowerCel™ 170 MiniCI-5527-1302026-10-26
00197420015445PowerCel™ 170 MiniCI-5527-1402026-10-26
00197420015469PowerCel™ 170 MiniCI-5527-1502026-10-26
00197420015483PowerCel™ 110CI-5511-1402026-10-26
00197420015506PowerCel™ 110CI-5511-1502026-10-26
00197420015520PowerCel™ 110CI-5511-1602026-10-26
00197420015544PowerCel™ 110CI-5511-1702026-10-26
00197420015568PowerCel™ 110CI-5511-1902026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197420015179PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015186PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015216PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015223PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015254PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015278PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015292PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015315PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015339PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015353PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015377PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015407PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015421PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015445PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015469PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015483PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015506PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015520PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015544PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015568PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015582PowerCel™ 110Advanced Bionics, LLCMCM2026-10-26
00197420015827PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015858PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015872PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015896PowerCel™ 110 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015964PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420015995PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420016008PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420016022PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26
00197420016046PowerCel™ 170 MiniAdvanced Bionics, LLCMCM2026-10-26