SAMBA 2 BB AP Unit, right

Primary DI
09008737525262
Brand
SAMBA 2 BB AP Unit, right
Company
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Model
52526
Device description
Audio Processor
Published
2020-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PFOActive Implantable Bone Conduction Hearing System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFOActive Implantable Bone Conduction Hearing SystemEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09008737525262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09008737525262090087375252629008737525262

GMDN Terms#

Term, Definition table
TermDefinition
Bone-conduction hearing implant system sound processorThe non-sterile external portion of a bone-conduction hearing implant system intended to compensate for impaired hearing by transmitting transduced sound vibrations through the skull to the inner ear. It is worn by the user (e.g., body-worn, head-worn) and typically consists of a battery-powered microphone/transmitter (transducer) designed to convert sound waves from the environment into electrical signals to transmit to a vibrator for the transmission of vibrations to the inner ear via bone conduction.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-25 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-13 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature-13 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-633-3524implants.us@medel.com

Regulatory Flags#

DUNS number
300764032
Device count
1
Serial number
true

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09008737461386SONNET Battery Pack Cover Standard Pro, Ebony461382026-02-26
09008737461393SONNET Battery Pack Cover Standard Pro, Nordic Gray461392026-02-26
09008737461409SONNET Battery Pack Cover Standard Pro, Beige461402026-02-26
09008737461416SONNET Battery Pack Cover Standard Pro, White461412026-02-26
09008737461423SONNET Battery Pack Cover Standard Pro, Black461422026-02-26
09008737461485SONNET Battery Pack Cover Micro Pro, Anthracite461482026-02-26
09008737461492SONNET Battery Pack Cover Micro Pro, Ebony461492026-02-26
09008737461508SONNET Battery Pack Cover Micro Pro, Nordic Gray461502026-02-26
09008737461515SONNET Battery Pack Cover Micro Pro, Beige461512026-02-26
09008737461522SONNET Battery Pack Cover Micro Pro, White461522026-02-26
09008737461539SONNET Battery Pack Cover Micro Pro, Black461532026-02-26
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