neoBLUE 030760

GUDID 00382830005678

Disposable mattress cover for the neoBLUE Cozy LED Phototherapy System

NATUS MEDICAL INCORPORATED

Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit 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

Trademark Results [neoBLUE]

Mark Image Registration \| Serial	Company Trademark Application Date
NEOBLUE 77256448 3466146 Live/Registered	Natus Medical Incorporated 2007-08-15