ALGO Newborn Hearing Screener 004691

GUDID 00382830043939

The ALGO 5 Newborn Hearing Screener is a mobile, cart-based, noninvasive instrument used to screen infants for hearing loss.

NATUS MEDICAL INCORPORATED

Evoked-potential audiometer Evoked-potential audiometer

• Primary Device ID: 00382830043939
• NIH Device Record Key: bcfc12cb-44e1-4d82-8fd8-d49d002cbe16
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALGO Newborn Hearing Screener
• Version Model Number: ALGO 5
• Catalog Number: 004691
• 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: false
• 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

Device Dimensions

• Weight: 140 Pound
• Weight: 140 Pound
• Weight: 140 Pound
• Weight: 140 Pound
• Depth: 19.5 Inch
• Width: 20 Inch
• Height: 61.5 Inch
• Weight: 140 Pound

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830043939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073665

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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: 2016-12-16

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