UNITRON
- Primary DI
- 07613389075823
- Brand
- UNITRON
- Company
- Unitron Hearing Division
- Model
- 088-5001
- Catalog number
- 088-5001
- Device description
- Unitron Remote Plus app
- Published
- 2019-01-16
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Related Records
Contact Domains
unitron.comProduct Codes
| Code | Name |
|---|---|
| OSM | Hearing aid, air conduction with wireless technology |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| OSM | Hearing Aid, Air-Conduction With Wireless Technology, Prescription | Ear, Nose, Throat | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 07613389075823 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 07613389075823 | 07613389075823 | 7613389075823 |
GMDN Terms
| Term | Definition |
|---|---|
| Audiometric/hearing device software | A software program intended to assist with the evaluation of a patient’s hearing capability and/or hearing assistive devices. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet). |
Sterilization Methods
| Method |
|---|
Contacts
| Phone | |
|---|---|
| +1 519 895 0100 | quality@unitron.com |
Regulatory Flags
- DUNS number
- 243202080
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 07613389468601 | Unitron | 050-6441-P6 | 050-6441-P6 | 2021-10-18 |
| 07613389468687 | Unitron | 050-6436-P6 | 050-6436-P6 | 2021-10-18 |
| 07613389468694 | Unitron | 050-6437-P6 | 050-6437-P6 | 2021-10-18 |
| 07613389468700 | Unitron | 050-6438-P6 | 050-6438-P6 | 2021-10-18 |
| 07613389469516 | Unitron | 050-6439-P6 | 050-6439-P6 | 2021-10-18 |
| 07613389469523 | Unitron | 050-6436-P2 | 050-6436-P2 | 2021-10-18 |
| 07613389469530 | Unitron | 050-6436-P4 | 050-6436-P4 | 2021-10-18 |
| 07613389469547 | Unitron | 050-6436-P7 | 050-6436-P7 | 2021-10-18 |
| 07613389469554 | Unitron | 050-6436-P8 | 050-6436-P8 | 2021-10-18 |
| 07613389469561 | Unitron | 050-6436-R8 | 050-6436-R8 | 2021-10-18 |
| 07613389469578 | Unitron | 050-6437-P2 | 050-6437-P2 | 2021-10-18 |
| 07613389469585 | Unitron | 050-6437-P4 | 050-6437-P4 | 2021-10-18 |
| 07613389469592 | Unitron | 050-6437-P7 | 050-6437-P7 | 2021-10-18 |
| 07613389469608 | Unitron | 050-6437-P8 | 050-6437-P8 | 2021-10-18 |
| 07613389469813 | Unitron | 050-6437-R8 | 050-6437-R8 | 2021-10-18 |
| 07613389469820 | Unitron | 050-6438-P2 | 050-6438-P2 | 2021-10-18 |
| 07613389469837 | Unitron | 050-6438-P4 | 050-6438-P4 | 2021-10-18 |
| 07613389469844 | Unitron | 050-6438-P7 | 050-6438-P7 | 2021-10-18 |
| 07613389469851 | Unitron | 050-6438-P8 | 050-6438-P8 | 2021-10-18 |
| 07613389469868 | Unitron | 050-6438-R8 | 050-6438-R8 | 2021-10-18 |
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| 05714880292244 | Widex | Widex A/S | OSM | 2026-05-22 |
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