Houva-NET Control System

GUDID 00816878020862

NATIONAL BIOLOGICAL CORPORATION

Ultraviolet phototherapy unit, home-use

• Primary Device ID: 00816878020862
• NIH Device Record Key: 5a9bbf1e-5bf7-4a2a-8630-fe6b62d7ec2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Houva-NET Control System
• Version Model Number: HNT-100
• 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	00816878020862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K827890

FDA Product Code

• FTC: Light, Ultraviolet, Dermatological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-12-21
• Device Publish Date: 2018-07-20

Devices Manufactured by NATIONAL BIOLOGICAL CORPORATION

• 00816878020671 - Handisol: 2024-04-11
• 00816878020800 - Handisol: 2024-04-11
• 00816878020893 - Panosol 6: 2024-03-21
• 00816878020909 - Panosol 6: 2024-03-21
• 00816878020916 - Panosol 6: 2024-03-21
• 00816878020923 - Panosol 6: 2024-03-21
• 00816878020930 - Panosol 6-3D: 2024-03-21
• 00816878020947 - Panosol 6-3D: 2024-03-21