NeoBLUE Nova

Basic Information

• Brand Name: NeoBLUE Nova
• Primary DI: 05713315011238
• Version / Model: 019040
• Catalog Number: 019040
• Company Name: Natus Medical Denmark ApS
• Labeler DUNS: 306633756
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-27
• Public Version: 3
• Public Version Date: 2025-12-19
• Public Version Status: Update
• Public Device Record Key: a19f69ea-5bca-4b82-9e37-64525a62d4f7

Device Description

neoBLUE Rollstand

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBI	Unit, Neonatal Phototherapy	General Hospital	880.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35239	Overhead infant phototherapy unit	A mains electricity (AC-powered) device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (hyperbilirubinemia). It consists of an overhead lamp consisting of several, daylight, cool white, blue, or special blue fluorescent light tubes and a Plexiglas shield placed between the phototherapy lights and the newborn to filter out ultraviolet (UV) radiation. Exposure to this device will alter the bilirubin through photo-oxidation, and configurational and structural isomerization, allowing the body to dispose of it naturally. It will typically have a built-in timer, but some may have a separate timer unit connected.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713315011238	GS1

Premarket Submissions

Submission Number	Supplement Number
K160745	000