FDA UDI
In Commercial Distribution
🇺🇸 United States
Widex
DI: 05706069664287
·
Model: PRO LINK
·
Widex A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Widex
- Primary DI
- 05706069664287
- Version / Model
- PRO LINK
- Catalog Number
- 8 927 0100 000
- Company Name
- Widex A/S
- Labeler DUNS
- 309843613
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-14
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 677ecadd-49a9-477a-9cbc-43ade8366a46
Device Description
PRO LINK
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 |
|---|---|---|---|---|
| 57884 | Hearing aid wireless-fitting computer-aided set | A collection of devices designed to work in conjunction with a computer to transmit wireless data to a hearing aid for computer-aided adjustment of the hearing aid while it is being fitted to a patient by healthcare personnel. It primarily consists of computer application software and a neck loop to establish the wireless link (the radio link protocol) with the hearing aid. The hearing aid must be compatible for wireless data reception and may be behind-the-ear (BTE), in-the-ear (ITE) and completely-in-the-canal (CIC) types. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05706069664287 | GS1 |
Customer Contacts
- Phone
- +4544355600
- [email protected]
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 5 – 50 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius