NeoBLUE Nova 019040

GUDID 05713315011238

neoBLUE Rollstand

Natus Medical Denmark ApS

Overhead infant phototherapy unit

• Primary Device ID: 05713315011238
• NIH Device Record Key: a19f69ea-5bca-4b82-9e37-64525a62d4f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeoBLUE Nova
• Version Model Number: 019040
• Catalog Number: 019040
• Company DUNS: 306633756
• Company Name: Natus Medical Denmark ApS
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05713315011238 [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: 2025-12-19
• Device Publish Date: 2025-05-27

Devices Manufactured by Natus Medical Denmark ApS

• 05713315011597 - RetCam Envision: 2026-02-18 RetCam Envision system with FA
• 05713315011641 - RetCam Envision: 2026-02-18 FA Upgrade kit for - RetCam Envision without FA
• 05713315011924 - RetCam Envision: 2026-02-18 Lens, 80 Degrees
• 05713315011931 - RetCam Envision: 2026-02-18 RetCam Envision 130 Degrees Lens
• 05713315011948 - RetCam Envision: 2026-02-18 RetCam Envision Portrait Lens
• 05713315011962 - RetCam Envision: 2026-02-18 RetCam Envision System Basix
• 05713315012068 - Echo-Screen III: 2026-02-06 Natus branded OAE Probe Body Nozzle (5/PKG)
• 05713315012013 - Echo-Screen III: 2026-02-05 ES III PCA Cable, 4'