FDA.reportPublic FDA data

Naida CI AquaCase™

Primary DI
07630016835247
Brand
Naida CI AquaCase™
Company
Advanced Bionics, LLC
Model
CI-7431
Published
2015-10-24
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
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
07630016835247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630016835247076300168352477630016835247

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

Sterilization Methods#

Method table
Method

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
00197420014578Zn-Air Battery PakCI-5500-2302026-10-23
00197420014592Zn-Air Battery PakCI-5500-2402026-10-23
00197420014615Zn-Air Battery PakCI-5500-1202026-10-23
00197420014639Zn-Air Battery PakCI-5500-1302026-10-23
00197420014653Zn-Air Battery PakCI-5500-1402026-10-23
00197420014677Zn-Air Battery PakCI-5500-1502026-10-23
00197420014691Zn-Air Battery PakCI-5500-1602026-10-23
00197420014714Zn-Air Battery PakCI-5500-1702026-10-23
00197420014738Zn-Air Battery PakCI-5500-1902026-10-23
00197420014752Zn-Air Battery PakCI-5500-1102026-10-23
00197420014776Zn-Air Battery PakCI-5500-2202026-10-23
00197420017456M Zn-Air Battery PakCI-5501-2802026-10-23
00197420017470M Zn-Air Battery PakCI-5501-2602026-10-23
00197420017494M Zn-Air Battery PakCI-5501-2702026-10-23
00197420017517M Zn-Air Battery PakCI-5501-1202026-10-23
00197420017531M Zn-Air Battery PakCI-5501-1302026-10-23
00197420017555M Zn-Air Battery PakCI-5501-1402026-10-23
00197420017579M Zn-Air Battery PakCI-5501-1502026-10-23
00197420017593M Zn-Air Battery PakCI-5501-1902026-10-23
00197420017616M Zn-Air Battery PakCI-5501-2502026-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197420014578Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014592Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014615Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014639Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014653Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014677Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014691Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014714Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014738Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014752Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420014776Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017456M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017470M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017494M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017517M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017531M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017555M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017579M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017593M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017616M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017630M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017654M Zn-Air Battery PakAdvanced Bionics, LLCMCM2026-10-23
00197420017999M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018002M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018033M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018057M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018071M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018095M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018118M BatteryAdvanced Bionics, LLCMCM2026-10-23
00197420018132M BatteryAdvanced Bionics, LLCMCM2026-10-23