4-Lamp 2' Panosol

GUDID 00816878020879

NATIONAL BIOLOGICAL CORPORATION

Ultraviolet phototherapy unit, home-use

• Primary Device ID: 00816878020879
• NIH Device Record Key: 4de7e4e1-f59c-4211-8505-19e99ec30750
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4-Lamp 2' Panosol
• Version Model Number: UVB-241
• Company DUNS: 046198420
• Company Name: NATIONAL BIOLOGICAL CORPORATION
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816878020879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K904427

FDA Product Code

• FTC: Light, Ultraviolet, Dermatological

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: 2018-11-16
• Device Publish Date: 2018-10-16