Bio-Logic Scout Sport 580-SPBOX1001

GUDID 00382830055031

Scout is a PC-based measurement system that performs otoacoustic emissions tests. Using a combination of hardware and software, each system produces a controlled acoustic signal in the ear canal and measures the resulting otoacoustic emission that is generated by outer hair cells in the cochlea. The system collects and averages data samples until specified measurement parameters are achieved.

NATUS MEDICAL INCORPORATED

Evoked-potential audiometer

• Primary Device ID: 00382830055031
• NIH Device Record Key: 34a9d2b2-f10c-4359-9107-c94ed27ff98e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Logic Scout Sport
• Version Model Number: 580-SPBOX1001
• Catalog Number: 580-SPBOX1001
• 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 Condition: 15-40 C
• Special Storage Condition, Specify: Between 0 and 0 *Operating Condition: 15-40 C
• Special Storage Condition, Specify: Between 0 and 0 *Operating Condition: 15-40 C
• Special Storage Condition, Specify: Between 0 and 0 *Operating Condition: 15-40 C
• Special Storage Condition, Specify: Between 0 and 0 *Operating Condition: 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
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Operating Condition: 15-40 C

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830055031 [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: 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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