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 ID: 00382830054980
• NIH Device Record Key: 4db4a646-756e-4ba0-9e1d-fb33db3fb87a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Logic AudX
• Version Model Number: 580-AXPBOX-018
• Catalog Number: 580-AXPBOX-018
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830054980 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-18
• Device Publish Date: 2018-12-18

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