DEVICE: Widex (05706069469813)
Device Identifier (DI) Information
Widex
ME-m
In Commercial Distribution
8 371 0201 021
Widex A/S
ME-m
In Commercial Distribution
8 371 0201 021
Widex A/S
Widex MENU ME-m BTE (Warm beige ) Switch
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
No | |
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No | |
No | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
34671 | Air-conduction hearing aid, behind-the-ear |
A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a microphone, an amplifier, and a speaker (receiver) contained in a case worn behind-the-ear (BTE). The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum through an earmould that fits inside the outer ear or a tube in the ear canal. The device is used for mild to profound hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ESD | Hearing Aid, Air Conduction |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -20 and 55 Degrees Celsius |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between 0 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
745b841a-bf45-4970-8b44-d8b43b58c8d7
October 06, 2020
3
January 08, 2017
October 06, 2020
3
January 08, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4544355600
widex@widex.com
widex@widex.com