AccessGUDID - DEVICE: Widex (05706069659788)

GUDID

Device Identifier (DI) Information

Brand Name: Widex
Version or Model: B-F2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8 393 0101 112
Company Name: Widex A/S

Primary DI Number: 05706069659788
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 309843613 *Terms of Use

Device Description: Widex BEYOND B-F2 (Silver white ) Telecoil, RC coil

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61475	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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OSM	Hearing Aid, Air Conduction With Wireless Technology

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 77989884-f20e-4522-a829-41a2214b1a3f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 18, 2016

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

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +4544355600
Email: widex@widex.com

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