DEVICE: Widex (05706069659788)

Device Identifier (DI) Information

Widex
B-F2
In Commercial Distribution
8 393 0101 112
Widex A/S
05706069659788
GS1

1
309843613 *Terms of Use
Widex BEYOND B-F2 (Silver white ) Telecoil, RC coil
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Hearing aid remote control application software An application software program intended to be used for adjustment of hearing aid acoustical settings (e.g., volume, program changes) by the patient. It is intended to run on a dedicated hearing aid remote control or an off-the-shelf portable computerized device (e.g., smartphone, tablet, laptop), with a wireless connection to the hearing aid. It does not store any patient demographic or clinical data. It typically includes upgrades to the software.
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FDA Product Code

[?]
Product Code Product Code Name
OSM Hearing Aid, Air Conduction With Wireless Technology
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -18 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

77989884-f20e-4522-a829-41a2214b1a3f
March 29, 2018
2
November 18, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+4544355600
widex@widex.com
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