Samba BB, Right

Basic Information

• Brand Name: Samba BB, Right
• Primary DI: 09008738515606
• Version / Model: 51560
• Company Name: Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
• Labeler DUNS: 300764032
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-09
• Public Version: 3
• Public Version Date: 2022-09-15
• Public Version Status: Update
• Public Device Record Key: 399d75a5-aec8-4ce1-8964-48957a2b1ced

Device Description

Audio Processor Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PFO	Implantable Bone Conduction Hearing Aid	Ear, Nose, Throat	874.3340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62209	Bone-conduction hearing implant system sound processor/vibrator	An electrically-powered, external device intended to compensate for impaired hearing by receiving sound waves from the environment and converting them into vibrations, which are transmitted to the inner ear via the temporal bone. It typically incorporates a microphone, transmitter/receiver and vibrator connected or magnetically coupled to vibrating implantable components (e.g., vibration transmission screw, partially-implantable abutment) for retention and transmission of vibrations to the inner ear; it may include positioning and protection devices. This device is typically used to treat hearing impairment due to middle and/or outer ear obstructive pathologies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008738515606	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN170009	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: – 93 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -13 – 140 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -13 – 140 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: -25 – 60 Degrees Celsius