FDA UDI
In Commercial Distribution
🇺🇸 United States
Sentiero AuDX PRO
DI: 04260223143472
·
Model: 8-04-16520
·
PATH medical GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sentiero AuDX PRO
- Primary DI
- 04260223143472
- Version / Model
- 8-04-16520
- Catalog Number
- 100250-BL-US3
- Company Name
- PATH medical GmbH
- Labeler DUNS
- 551540334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-01
- Public Version
- 3
- Public Version Date
- 2020-06-24
- Public Version Status
- Update
- Public Device Record Key
- 609fc6c7-09e4-484a-a66c-957292044d83
Device Description
Sentiero AuDX PRO Set Content: 1. Sentiero Diagnostic device AN100098-AUP 2. Carrying case AN100928 3. Inlay AN100677 4. Probe EP-DP Path long AN100028-US 5. Accessory box Combo AB-03 AN100261-BL 6. DPOAE Software AN100110 7. FMDPOAE Software AN100536 8. DPHiRes Software AN100537 9. Software label printer AN100414 10. PC Patient Management Software AN100116 11. USB data cable AN100089 12. USB stick Bio-Logic AN100724-BL 13. Power supply Sentiero AN101013+AN100993-USA 14. Manual Bio-Logic AN100904-EN-BL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| GWJ | Stimulator, Auditory, Evoked Response | Neurology | 882.1900 | 2 |
| EWO | Audiometer | Ear, Nose, Throat | 874.1050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35747 | Evoked-potential audiometer | An electroacoustic instrument designed to evaluate the activity of the auditory pathway of the brain in response to an acoustic signal [auditory brainstem response (ABR)] it provides at the ear (e.g., clicks delivered through an earphone), without need of patient cooperation. The signal, detected via the device's scalp electrodes and possibly a reference electrode on the ear lobe, is measured using computer averaging and signal processing techniques. This device is typically used to assess the function of the auditory pathways and to differentiate coma due to metabolic factors from structural damage. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260223143472 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133012 | 000 |