FDA UDI
In Commercial Distribution
🇺🇸 United States
Sentiero Desktop AuDX PRO FLEX
DI: 04260223143540
·
Model: 8-04-16540
·
PATH medical GmbH
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sentiero Desktop AuDX PRO FLEX
- Primary DI
- 04260223143540
- Version / Model
- 8-04-16540
- Catalog Number
- 100497-BL-US1
- 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
- 4
- Public Version Date
- 2022-09-29
- Public Version Status
- Update
- Public Device Record Key
- 24f73d05-0923-47d0-a743-0ee36ffcddaa
Device Description
Sentiero Desktop AuDX PRO FLEX Set: Content: 1. Sentiero Desktop AN100434-AUPF 2. Cardboard Box AN100728 3. Cardboard Sleeve Bio-Logic AN100723-Biologic 4. Probe EP-TY long AN100188-US 5. Accessory box Combo AB-03 AN100261-BL 6. Accessory box AB08 AN100734-P 7. FW Screening Tymp class 2 AN100560 8. Software label printer AN100414 9. USB data cable AN100418 10. USB stick Bio-Logic AN100724-BL 11. Test cavity tymp AN100549 12. Power supply Sentiero Desktop FW7662M AN100524 or FW8002.1M AN101360 optionally 13. Power supply adapter Sentiero Desktop US AN100525-USA or AN101251-USA optionally 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 |
|---|---|---|---|---|
| ETY | Tester, Auditory Impedance | Ear, Nose, Throat | 874.1090 | 2 |
| 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 | 04260223143540 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133012 | 000 |