FDA.reportPublic FDA data

Naida CI Q30

Primary DI
00840094413061
Brand
Naida CI Q30
Company
Advanced Bionics, LLC
Model
CI-5260-120
Device description
sand beige
Published
2026-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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
P960058171

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P960058171CLARION MULTI-STRATEGY COCHLEAR IMPLANTAdvanced Bionics1997-06-26MCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840094413061PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840094413061008400944130618400944130610840094413061

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 Atmospheric Pressure00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
803906382
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840094414891Naida CI Q30CI-5260-1202026-10-22
00840094419810Naida CI Q30CI-5260-1402026-10-22
00840094421783Naida CI Q30CI-5260-1402026-10-22
00840094427433Naida CI Q30CI-5260-1502026-10-22
00840094431072Naida CI Q30CI-5260-1502026-10-22
00840094433663Naida CI Q90CI-5280-1202026-10-22
00840094433687Naida CI Q90CI-5280-1202026-10-22
00840094433908Naida CI Q90CI-5280-1302026-10-22
00840094433953Naida CI Q90CI-5280-1302026-10-22
00840094434011Naida CI Q90CI-5280-1402026-10-22
00840094434073Naida CI Q90CI-5280-1402026-10-22
00840094434103Naida CI Q90CI-5280-1502026-10-22
00840094434134Naida CI Q90CI-5280-1502026-10-22
00840094434202Naida CI Q90CI-5280-1602026-10-22
00840094435414Naida CI Q90CI-5280-1602026-10-22
00840094445499Naida CI Q90CI-5280-1702026-10-22
00840094445505Naida CI Q90CI-5280-1702026-10-22
00840094445512Naida CI Q90CI-5280-1902026-10-22
00840094445574Naida CI Q90CI-5280-1902026-10-22
00840094467033Naida CI Q90CI-5280-1102026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840094414891Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094419810Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094421783Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094427433Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094431072Naida CI Q30Advanced Bionics, LLCMCM2026-10-22
00840094433663Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094433687Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094433908Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094433953Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434011Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434073Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434103Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434134Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094434202Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094435414Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094445499Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094445505Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094445512Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094445574Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094467033Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094467064Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094468924Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094480643Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094481138Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094481510Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094482548Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094483811Naida CI Q90Advanced Bionics, LLCMCM2026-10-22
00840094486362Naida CI M90Advanced Bionics, LLCMCM2026-10-22
00840094486379Naida CI M90Advanced Bionics, LLCMCM2026-10-22
00840094486386Naida CI M90Advanced Bionics, LLCMCM2026-10-22