BiliSoft Phototherapy System

GUDID 00840682116534

DATEX-OHMEDA INC

Overhead infant phototherapy unit

• Primary Device ID: 00840682116534
• NIH Device Record Key: 001184ce-dab7-4f43-8b11-b2022b612ea1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BiliSoft Phototherapy System
• Version Model Number: BI2
• Company DUNS: 131483356
• Company Name: DATEX-OHMEDA 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: false
• 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	00840682116534 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-24

On-Brand Devices [BiliSoft Phototherapy System]

• 00840682116565: BI1
• 00840682116558: BI3
• 00840682116534: BI2