SAMBA 2 Hi AP unit, left

Basic Information

• Brand Name: SAMBA 2 Hi AP unit, left
• Primary DI: 09008737525293
• Version / Model: 52529
• 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: 2022-12-05
• Public Version: 2
• Public Version Date: 2023-06-20
• Public Version Status: Update
• Public Device Record Key: 31d66409-d641-47d2-b34d-85968d0af851

Device Description

Audio Processor

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
MPV	Implant, Hearing, Active, Middle Ear, Partially Implanted	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
47369	Partially-implantable middle ear implant system sound processor	The non-sterile external portion of a partially-implantable middle ear implant system that typically consists of a battery-powered microphone, signal analysis and filtering unit, radio-frequency (RF) modulator and amplifier, and an RF transmitter and antenna. These components receive sound waves from the environment, convert them into electrical signals (radio waves), and transmit the signals to the implantable portion of the system which activates the auditory pathway by vibrating the ossicles (middle ear bones).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008737525293	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P990052	026

Storage Conditions

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