SAMBA 2 52612

GUDID 09008737526122

SAMBA 2 BB User Kit, left

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

Bone-conduction hearing implant system sound processor

• Primary Device ID: 09008737526122
• NIH Device Record Key: a24fd215-db56-4074-bd6d-8dafbbdd8dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAMBA 2
• Version Model Number: 52612
• Catalog Number: 52612
• Company DUNS: 300764032
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com
• Phone: 1-888-633-3524
• Email: implants.us@medel.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008737526122 [Primary]

FDA Product Code

• PFO: Active Implantable Bone Conduction Hearing System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-16
• Device Publish Date: 2020-09-08

On-Brand Devices [SAMBA 2]

• 09008737527969: Remote Control
• 09008737526122: SAMBA 2 BB User Kit, left
• 09008737526115: SAMBA 2 BB User Kit, right
• 09008737526030: SAMBA 2 Remote (iOS)
• 09008737525279: SAMBA 2 BB AP Unit, left
• 09008737525262: SAMBA 2 BB AP Unit, right
• 09008737525071: SAMBA 2 GO
• 09008737520472: SAMBA 2 Remote (Android)