Scout Sport Otoacoustic Emissions Measurement System 580-SP2191

GUDID 00382830001618

The Scout Sport Otoacoustix Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE input/output (I/O) tests.

NATUS MEDICAL INCORPORATED

Evoked-potential audiometer

• Primary Device ID: 00382830001618
• NIH Device Record Key: 071f8764-a825-428f-9e90-e9babd471b44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scout Sport Otoacoustic Emissions Measurement System
• Version Model Number: Scout Sport
• Catalog Number: 580-SP2191
• 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 Temperature: 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	00382830001618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121512

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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