Bilisoft 2.0

GUDID 00812432020460

The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in a hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.

LUMITEX, INC.

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: 00812432020460
• NIH Device Record Key: 87dfcfaf-e860-489c-8fcb-d6e919343522
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bilisoft 2.0
• Version Model Number: 009766
• Company DUNS: 108631797
• Company Name: LUMITEX, 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: 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	00812432020460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053568

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: 1
• Public Version Date: 2018-12-17
• Device Publish Date: 2018-11-15

On-Brand Devices [Bilisoft 2.0]

• 00812432020484: The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperb
• 00812432020477: The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperb
• 00812432020460: The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperb
• 00812432020453: The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperb