SAMBA 2 BB PoM, left

GUDID 09008737525330

Audio Processor

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

Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator Bone-conduction hearing implant system sound processor/vibrator

• Primary Device ID: 09008737525330
• NIH Device Record Key: fb3042ae-615c-4196-9983-f11df7be4a4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAMBA 2 BB PoM, left
• Version Model Number: 52533
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09008737525330 [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: 2023-07-13
• Device Publish Date: 2023-07-05

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• 09008737525316 - SAMBA 2 Lo AP unit, left: 2023-06-20 Audio Processor