AccessGUDID - DEVICE: Bio-Logic AudX (00382830054980)

GUDID

Device Identifier (DI) Information

Brand Name: Bio-Logic AudX
Version or Model: 580-AXPBOX-018
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 580-AXPBOX-018
Company Name: NATUS MEDICAL INCORPORATED

Primary DI Number: 00382830054980
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962519208 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWO	Audiometer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K111618	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Atmospheric Pressure: <81kPA (<2000 meters)
Special Storage Condition, Specify: Storage Humidity: 0-90% at 65 C
Special Storage Condition, Specify: Operating Humidity: 15%-95% at 40 C Non-Condensing
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Special Storage Condition, Specify: Operating Temperature: 15-40 C

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4db4a646-756e-4ba0-9e1d-fb33db3fb87a
Public Version Date: January 18, 2019
Public Version Number: 1
DI Record Publish Date: December 18, 2018