Ultra Bili Light UBL5000

GUDID 00183415000107

PHYSICIAN ENGINEERED PRODUCTS INC

Overhead infant phototherapy unit

• Primary Device ID: 00183415000107
• NIH Device Record Key: 0cf7d4e1-6119-421a-9639-5d9a2c46b6ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra Bili Light
• Version Model Number: 2000
• Catalog Number: UBL5000
• Company DUNS: 144657848
• Company Name: PHYSICIAN ENGINEERED PRODUCTS 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-622-6240
• Email: Info@PEPonline.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00183415000107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974830

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: 2018-07-06
• Device Publish Date: 2017-08-03