neoBLUE 030760

GUDID 00382830005678

Disposable mattress cover for the neoBLUE Cozy LED Phototherapy System

NATUS MEDICAL INCORPORATED

Blanket/pad infant phototherapy unit

• Primary Device ID: 00382830005678
• NIH Device Record Key: 00b4cb69-a7ad-49c0-9e3b-5db5edb9b13e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neoBLUE
• Version Model Number: Cozy Disposable Mattress Cover
• Catalog Number: 030760
• Company DUNS: 962519208
• Company Name: NATUS MEDICAL INCORPORATED
• Device Count: 50
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
• 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

Device Dimensions

• Width: 10.41 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch
• Length: 22 Inch
• Width: 10.41 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830005678 [Primary]
GS1	00382830053204 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051869

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: 2016-12-29

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