neoBLUE Compact LED Phototherapy System 018000, 019051, 019001, 019011

GUDID 00382830016773

The neoBLUE compact LED Phototherapy System is a portable phototherapy light that delivers a narrow band of high-intensity blue light via light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE® compact LED Phototherapy System can be used in three different configurations: the light source (light) can be used alone, with the neoBLUE compact arm, and with the neoBLUE compact roll stand.

NATUS MEDICAL INCORPORATED

Overhead infant phototherapy unit

• Primary Device ID: 00382830016773
• NIH Device Record Key: f309ec9b-0981-49c1-9a23-24d44ee79a15
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neoBLUE Compact LED Phototherapy System
• Version Model Number: neoBLUE compact
• Catalog Number: 018000, 019051, 019001, 019011
• 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 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830016773 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160745

FDA Product Code

• LBI: Unit, Neonatal Phototherapy

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: 2017-04-14

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