neoBLUE 024738, 024915

GUDID 00382830053686

neoBLUE blanket Light Box

NATUS MEDICAL INCORPORATED

Blanket/pad infant phototherapy unit

• Primary Device ID: 00382830053686
• NIH Device Record Key: 7d9dd4a9-041f-460b-b6a2-ba17468a6d56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neoBLUE
• Version Model Number: blanket Light Box
• Catalog Number: 024738, 024915
• Company DUNS: 962519208
• Company Name: NATUS MEDICAL INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: 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
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• Phone: 1-800-303-0306
• Email: technical_service@natus.com
• 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 -30 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage 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 0 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 65 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830053686 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182178

FDA Product Code

• LBI: Unit, Neonatal Phototherapy

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: 2019-01-17
• Device Publish Date: 2018-12-17

On-Brand Devices [neoBLUE]

• 00382830053686: neoBLUE blanket Light Box
• 00382830053198: The neoBLUE cozy™ Phototherapy System is a mobile phototherapy light that delivers a narrow ba
• 00382830015523: neoBLUE blanket Small Disposable Mattress Cover
• 00382830015516: neoBLUE blanket Large Disposable Mattress Cover
• 00382830015431: neoBLUE blanket Small Mattress
• 00382830015424: neoBLUE blanket Large Mattress
• 00382830015417: neoBLUE blanket Small Pad Kit
• 00382830015394: neoBLUE blanket Large Pad Kit
• 00382830005678: Disposable mattress cover for the neoBLUE Cozy LED Phototherapy System