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 Evoked-potential audiometer

• Primary Device ID: 00382830001588
• NIH Device Record Key: f188de41-6985-4a49-a8fd-4cb34e5a0868
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AuDX Otoacoutic Emissions Measurement System wirh AuDX I/O Function
• Version Model Number: AuDX
• Catalog Number: 580-AX2191
• Company DUNS: 962519208
• Company Name: NATUS MEDICAL INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-303-0306
• Email: Technical_service@natus.com
• Phone: 1-800-303-0306
• Email: Technical_service@natus.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between -20 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830001588 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111618

FDA Product Code

• EWO: Audiometer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-11

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