FDA.reportPublic FDA data

Zn-Air Battery Pak

Primary DI
00197420014615
Brand
Zn-Air Battery Pak
Company
Advanced Bionics, LLC
Model
CI-5500-120
Device description
sand beige
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00197420014615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00197420014615001974200146151974200146150197420014615

GMDN Terms#

Term, Definition table
TermDefinition
Cochlear implant/auditory brainstem implant external batteryAn external component of a cochlear implant (CI) or auditory brainstem implant system designed to supply direct current (DC) to operate the electrically-powered and dependent components of the system. It is typically worn behind-the-ear (BTE), or is neck- or waist-worn, and may include an on/off switch. This is a reusable device.

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
true
Serial number
false
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
00197420014578Zn-Air Battery PakCI-5500-2302026-10-23
00197420014592Zn-Air Battery PakCI-5500-2402026-10-23
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
00197420017630M Zn-Air Battery PakCI-5501-1102026-10-23

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
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
00197420018156M BatteryAdvanced Bionics, LLCMCM2026-10-23