SONNET 2 EAS Audio Processor 37566

GUDID 09008737375669

SONNET 2 EAS Me1520 (AXIAL BAT) beige

Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Cochlear implant system sound processor
Primary Device ID09008737375669
NIH Device Record Key6c13cd42-c317-4c9c-8ca6-e25b4c9e5310
Commercial Distribution StatusIn Commercial Distribution
Brand NameSONNET 2 EAS Audio Processor
Version Model Number37566
Catalog Number37566
Company DUNS300764032
Company NameMed-El Elektromedizinische Geräte Gesellschaft m.b.H.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com
Phone1-888-633-3524
Emailimplants.us@medel.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Handling Environment TemperatureBetween 0 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -25 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS109008737375669 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCMImplant, Cochlear
PGQCochlear Implant With Combined Electrical Stimulation And Acoustic Amplification

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-28
Device Publish Date2019-10-18

Devices Manufactured by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

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09008737369736 - ANTS Connector Cable2024-11-01 Cable
09008737370053 - Stimulator Box2024-11-01 Hardware Interface System
09008737371371 - ANTS Electrode2024-11-01 Diagnostic Electrode
09008737405557 - Insertion Probe L2024-11-01 Single-Use Surgical Tool
09008737415433 - Mi1250 SYNCHRONY 2 PIN FLEX34 S-Vector Magnet2024-10-23 Cochlear Implant
09008737415440 - Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet2024-10-23 Cochlear Implant
09008737416218 - Insertion Electrode FLEX342024-10-23 Insertion Electrode

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