ADVANCED LED PHOTOTHERAPY LAMP

GUDID B510PT2000

ADVANCED INSTRUMENTATIONS, INC.

Overhead infant phototherapy unit

• Primary Device ID: B510PT2000
• NIH Device Record Key: 8835ecde-f091-4af9-97d8-36e2b1e8ac82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADVANCED LED PHOTOTHERAPY LAMP
• Version Model Number: PT-2000
• Company DUNS: 608736880
• Company Name: ADVANCED INSTRUMENTATIONS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B510PT2000 [Primary]

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: 2025-02-17
• Device Publish Date: 2025-02-07

On-Brand Devices [ADVANCED LED PHOTOTHERAPY LAMP]

• B510PT5000: PT-5000
• B510PT2000: PT-2000