M Zn-Air Battery Pak

GUDID 07630016880414

Caribbean Pirate

Advanced Bionics AG

Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack Cochlear implant system battery pack
Primary Device ID07630016880414
NIH Device Record Key0e7a9268-331c-42a1-b8d8-73d41967ba1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameM Zn-Air Battery Pak
Version Model NumberCI-5501-190
Company DUNS485262658
Company NameAdvanced Bionics AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx
Phone+1(661)362-1400
Emailxxx@xxx.xxx

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -20 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]
GS107630016880414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear
MCMImplant, Cochlear

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-22
Device Publish Date2021-02-12

On-Brand Devices [M Zn-Air Battery Pak ]

07630016880445Resin Beige
07630016880438Alpine White
07630016880421Precious Pink
07630016880407Velvet Black
07630016880391Silver Gray
07630016880384Chestnut
07630016880377Sand Beige
07630016880360Majesty Purple
07630016880353Blue Ocean
07630016880346Lava Red
07630016880414Caribbean Pirate

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