Sentiero Advanced
Basic Information
- Brand Name
- Sentiero Advanced
- Primary DI
- 04260223141614
- Version / Model
- 100340-US3
- Company Name
- PATH medical GmbH
- Labeler DUNS
- 551540334
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-31
- Public Version
- 6
- Public Version Date
- 2022-06-30
- Public Version Status
- Update
- Public Device Record Key
- f5eb3e3f-5ff6-4cf5-90a6-d6137c614a6f
Device Description
Sentiero Advanced ABR US3 Content: 1. Case AN100503 2. Inlay Sentiero AN100527 3. USB data cable AN100089 4. Path electrodes: 30 pcs. / bag. Each bag contains 10 sets of 3 pcs. AN 100468 5. Sentiero Advanced device with touchscreen AN100360 6. ABR electrode cable AN100307 7. Probe EP-DP Path AN100028-US 8. Headphone Sennheiser HDA 280 calibrated, incl. EEPROM AN100117 9. Bone conductor B81 calibrated AN100888 or B71W AN100344 optionally 10. Patient button (Sentiero A) AN100343 11. Binaural ABR Diagnostics SW, time saving up to 40%. Broadband Chirp and click Stimuli to be used with Headphone or Ear Probe or Oto insert phone. AN100424 12. Firmware PTA class 3 AN100114 13. DPOAE Software AN100110 14. TEOAE Software AN100109 15. DPHiRES Software AN100537 16. FMDPOAE Software AN100536 17. DPOAE Threshold Estimation Software AN100111 18. PC based Patient Management, Mira Software: Patient data & result transfer from instrument to PC, reporting options, export functions, printing via PC, data archive for Windows 10, Windows 7 etc. AN100116 19. Software label printer AN100414 20. Accessory box Sentiero Screening AN100676 21. Power pack Sentiero Advanced AN101016 + AN100993-USA
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 |
|---|---|---|---|---|
| EWO | Audiometer | Ear, Nose, Throat | 874.1050 | 2 |
| GWJ | Stimulator, Auditory, Evoked Response | Neurology | 882.1900 | 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 | 04260223141614 | GS1 |