BiliLux Phototherapy Light

GUDID 04049098094900

BiliLux LED Phototherapy System

DRAEGER MEDICAL SYSTEMS, INC.

Overhead infant phototherapy unit

• Primary Device ID: 04049098094900
• NIH Device Record Key: 25232905-8262-451f-80ba-d2b0d4b74390
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiliLux Phototherapy Light
• Version Model Number: MU20100
• Company DUNS: 788289952
• Company Name: DRAEGER MEDICAL SYSTEMS, INC.
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18004372437
• Email: info@draeger.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04049098094900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172656

FDA Product Code

• LBI: Unit, Neonatal Phototherapy

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-11

Devices Manufactured by DRAEGER MEDICAL SYSTEMS, INC.

• 04049098099042 - Babyroo TN300 Infant Radiant Warmer: 2023-06-16
• 04049098002035 - INFINITY M300 Nellcor WPA2: 2020-02-06
• 04049098002066 - Infinity M300 Masimo WPA2: 2020-02-06
• 04049098002172 - Omega-S Solution: 2020-02-06
• 04049098003858 - Infinity Vista XL Monitor: 2020-02-06
• 04049098003865 - INFINITY GAMMMA XL: 2020-02-06
• 04049098004022 - Vista Monitor: 2020-02-06
• 04049098004039 - Infinity Kappa Monitor: 2020-02-06