FDA UDI
In Commercial Distribution
🇺🇸 United States
Widex
DI: 05706069659788
·
Model: B-F2
·
Widex A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Widex
- Primary DI
- 05706069659788
- Version / Model
- B-F2
- Catalog Number
- 8 393 0101 112
- Company Name
- Widex A/S
- Labeler DUNS
- 309843613
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-18
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 77989884-f20e-4522-a829-41a2214b1a3f
Device Description
Widex BEYOND B-F2 (Silver white ) Telecoil, RC coil
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| OSM | Hearing Aid, Air Conduction With Wireless Technology | Ear, Nose, Throat | 874.3305 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05706069659788 | GS1 |
Customer Contacts
- Phone
- +4544355600
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -18 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 50 Degrees Celsius