BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

SAMBA 2 BB AP Unit, right

DI: 09008737525262 · Model: 52526 · Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: SAMBA 2 BB AP Unit, right
Primary DI: 09008737525262
Version / Model: 52526
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: 2022-09-15
Public Version Status: Update
Public Device Record Key: 0d36354c-5b19-4931-935d-575917404f21

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
PFO	Active Implantable Bone Conduction Hearing System	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	09008737525262	GS1

Customer Contacts

Phone: 1-888-633-3524
Email: [email protected]

Storage Conditions

Type: Handling Environment Humidity
Temperature Range: 10 – 90 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: -25 – 60 Degrees Celsius
Type: Handling Environment Temperature
Temperature Range: -13 – 140 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 – 90 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -25 – 60 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: -13 – 140 Degrees Fahrenheit