Bio-Logic AudX

Basic Information

• Brand Name: Bio-Logic AudX
• Primary DI: 00382830054973
• Version / Model: 580-AXBBOX-001
• Catalog Number: 580-AXBBOX-001
• Company Name: NATUS MEDICAL INCORPORATED
• Labeler DUNS: 962519208
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-17
• Public Version: 1
• Public Version Date: 2019-01-17
• Public Version Status: New
• Public Device Record Key: 8ca1ad1d-7ec7-4adb-acc3-9d8e5605413b

Device Description

The AuDX Box with DPOAE 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 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	00382830054973	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K111618	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Pressure: <81kPA (<2000 meters)
• Type: Special Storage Condition, Specify
• Special Conditions: Storage Humidity: 0-90% at 65 Deg C
• Type: Special Storage Condition, Specify
• Special Conditions: Operating Humidity: 0-95% at 40 Deg C Non-Condensing
• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Operating Temperature 15-40 Deg C