SAMBA 2 GO

Basic Information

• Brand Name: SAMBA 2 GO
• Primary DI: 09008737525071
• Version / Model: 52507
• 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: 2020-09-08
• Public Version: 3
• Public Version Date: 2022-11-14
• Public Version Status: Update
• Public Device Record Key: 0a43629e-13b2-4056-b711-fa55289a45ce

Device Description

Audio Processor Streaming Device

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	Active Implantable Bone Conduction Hearing System	Ear, Nose, Throat	874.3340	2
MPV	Implant, Hearing, Active, Middle Ear, Partially Implanted	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60259	Hearing aid/implant system functionality-enhancing device	An electrically-powered device designed to use a wired or wireless connection to a hearing aid (e.g., bone-conduction) or hearing implant system (e.g., cochlear, bone-conduction, partially-implantable middle ear) sound processor to enhance its functionality and/or sound quality [e.g., enable transmission from a multimedia device (e.g., computer, phone, mp3 player) to the hearing device]. It is typically a transmitter/receiver in the form of a microphone, an audio jack, room loop receiver/booster, small attachment and/or a wireless connection receiver. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09008737525071	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 10 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 50 – 104 Degrees Fahrenheit