FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sentiero Basic AuDX Set
DI: 04260223143335
·
Model: 100250-BL1
·
PATH medical GmbH
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sentiero Basic AuDX Set
- Primary DI
- 04260223143335
- Version / Model
- 100250-BL1
- Company Name
- PATH medical GmbH
- Labeler DUNS
- 551540334
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-10
- Public Version
- 3
- Public Version Date
- 2020-06-30
- Public Version Status
- Update
- Public Device Record Key
- a6340d9a-a04d-4a17-a587-f9d6940666f2
- Distribution End Date
- 2020-06-29
Device Description
Basic Set for AuDX branded Sentiero Content: - carrying bag A/N100503 - USB cable A/N100089 - AuDX A/N100098-AU - Headphone HB7/DD45 A/N100306-US - Probe EP-DP PATH long A/N100028-US - FW TEOAE Quick A/N100109-QUICK - FW DPOAE Quick A/N100110-QUICK - FW FMDPOAE A/N100536 - FW PTA Class 4 Advanced A/N100653 - FW Magic A/N100112 - FW Mira PC- Software A/N100116 - FW Labelprinter A/N100414 - Accessory box combo A/N100261 - Power Supply Sentiero US A/N100083-US - User Manual A/N100904-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 | 04260223143335 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K133012 | 000 |