Bio-Logic AudX 580-AXPBOX-018

GUDID 00382830054980

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.

NATUS MEDICAL INCORPORATED

Evoked-potential audiometer
Primary Device ID00382830054980
NIH Device Record Key4db4a646-756e-4ba0-9e1d-fb33db3fb87a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBio-Logic AudX
Version Model Number580-AXPBOX-018
Catalog Number580-AXPBOX-018
Company DUNS962519208
Company NameNATUS MEDICAL INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-303-0306
EmailTechnical_service@natus.com
Phone1-800-303-0306
EmailTechnical_service@natus.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Operating Temperature: 15-40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Operating Temperature: 15-40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Operating Temperature: 15-40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Operating Temperature: 15-40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Operating Temperature: 15-40 C
Special Storage Condition, SpecifyBetween 0 and 0 *Atmospheric Pressure:
Special Storage Condition, SpecifyBetween 0 and 0 *Storage Humidity: 0-90% at 65 C
Special Storage Condition, SpecifyBetween 0 and 0 *Operating Humidity: 15%-95% at 40 C Non-Condensing
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Operating Temperature: 15-40 C

Device Identifiers

Device Issuing AgencyDevice ID
GS100382830054980 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EWOAudiometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-18
Device Publish Date2018-12-18

On-Brand Devices [Bio-Logic AudX]

00382830055130The AuDX Pro Otoacoustic Emissions Measurement System produces controlled acoustic signals in th
00382830055093The AuDX Pro Otoacoustic Emissions Measurement System produces controlled acoustic signals in th
00382830055055The AuDX Pro Otoacoustic Emissions Measurement System produces controlled acoustic signals in th
00382830055048The AuDX Box with TEOAE Otoacoustic Emissions Measurement System produces controlled acoustic si
00382830054980The AuDX Pro Otoacoustic Emissions Measurement System produces controlled acoustic signals in th
00382830054973The AuDX Box with DPOAE Otoacoustic Emissions Measurement System produces controlled acoustic si
00382830054959The AuDX Otoacoustic Emissions Measurement System Basic box with DPOAE produces controlled acous
00382830054454The AuDX Pro Otoacoustic Emissions Measurement System produces controlled acoustic signals in th
00382830054447The AuDX Pro Otoacoustic Emissions Measurement System produces controlled acoustic signals in th

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