FDA UDI
In Commercial Distribution
🇺🇸 United States
Bio-Logic AudX
DI: 00382830054980
·
Model: 580-AXPBOX-018
·
NATUS MEDICAL INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Bio-Logic AudX
- Primary DI
- 00382830054980
- Version / Model
- 580-AXPBOX-018
- Catalog Number
- 580-AXPBOX-018
- Company Name
- NATUS MEDICAL INCORPORATED
- Labeler DUNS
- 962519208
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-18
- Public Version
- 1
- Public Version Date
- 2019-01-18
- Public Version Status
- New
- Public Device Record Key
- 4db4a646-756e-4ba0-9e1d-fb33db3fb87a
Device Description
The AuDX Pro Otoacoustic Emissions Measurement System produces controlled acoustic signals in the earcanal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear as a result of normal peripheral hearing processes. The AuDX Pro device performs both transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests that can be utilized in hearing screening and diagnostic test environments.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- 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 |
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 | 00382830054980 | GS1 |
Customer Contacts
- Phone
- 1-800-303-0306
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111618 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Atmospheric Pressure: <81kPA (<2000 meters)
- Type
- Special Storage Condition, Specify
- Special Conditions
- Storage Humidity: 0-90% at 65 C
- Type
- Special Storage Condition, Specify
- Special Conditions
- Operating Humidity: 15%-95% at 40 C Non-Condensing
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Operating Temperature: 15-40 C