AuDX Pro Otoacoustic Emissions Measurement System

Primary DI
00382830001595
Brand
AuDX Pro Otoacoustic Emissions Measurement System
Company
NATUS MEDICAL INCORPORATED
Model
AuDX Pro
Catalog number
580-AXPRO1
Device description
The AuDX Pro Otoacoustic Emissions Measurement System is a handheld battery operated device that performs otoacoustic emissions tests. Connection to the patient's ear is via the Bio-logic ear probe. Using a combination of hardware and software, the system produces a controlled acoustic signal in the ear canal and measures the resultiing evoked emissions that are generated by the outer hair cells of the inner ear associated with normal cochlear function. The stimuli are presented via miniature receivers and the acoustic response in the external ear canal is recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved.
Published
2017-09-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EWOAudiometer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EWOAudiometerEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122496000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122496000AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEMBio-Logic Systems Corp.2012-11-01EWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830001595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830001595003828300015953828300015950382830001595

GMDN Terms#

Term, Definition table
TermDefinition
Evoked-potential audiometerAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-303-0306Technical_service@natus.com

Regulatory Flags#

DUNS number
962519208
Device count
1
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Model table
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00382830000826Bio-logicOAE Tree Tip Preemie2032192017-03-31
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