AuDX Otoacoutic Emissions Measurement System wirh AuDX I/O Function 580-AX2191

GUDID 00382830001588

The AuDX I/O Function is a Windows based softwsre application for use with the AuDX otoacoustic Emissions Measurement System. The AuDX I/O software enables the AuDX device user to perform DPOAE testing at different test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level presented versus measured DPOAE level provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE responses.

NATUS MEDICAL INCORPORATED

Evoked-potential audiometer
Primary Device ID00382830001588
NIH Device Record Keyf188de41-6985-4a49-a8fd-4cb34e5a0868
Commercial Distribution StatusIn Commercial Distribution
Brand NameAuDX Otoacoutic Emissions Measurement System wirh AuDX I/O Function
Version Model NumberAuDX
Catalog Number580-AX2191
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
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

Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween -20 Degrees Celsius and 70 Degrees Celsius
Handling Environment TemperatureBetween 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382830001588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EWOAudiometer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-09-11

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