UVBioTek 800B

GUDID B343B800

Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient. 8 lamps, each 72" in height.

Medtek Lighting Corporation

Ultraviolet phototherapy unit, professional

• Primary Device ID: B343B800
• NIH Device Record Key: 350684ad-16c3-4a9e-8ce6-20ee2cb6f8c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UVBioTek
• Version Model Number: 800B
• Catalog Number: 800B
• Company DUNS: 002692106
• Company Name: Medtek Lighting Corporation
• Device Count: 1
• DM Exempt: true
• 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

Device Dimensions

• Weight: 400 Pound
• Area/Surface Area: 4480 Square inch
• Weight: 400 Pound
• Area/Surface Area: 4480 Square inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B343B800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933952

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: 4
• Public Version Date: 2018-12-21
• Device Publish Date: 2017-02-09

On-Brand Devices [UVBioTek]

• B343VL1400: Phototherapy Unit. UVB Narrow Band. Portable unit, on Stand with Casters. Multiple Vertical and
• B343ML600: Phototherapy Unit. UVB Narrow Band. Portable/Table top mounting. Home or Clinic Use.
• B343MD3: Phototherapy Unit. UVB Narrowband. 3 connected panels, 2 panels adjustable. Mounted to wall or s
• B343B800: Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient.
• B343B80: Phototherapy Unit. UVB Narrowband. Single upright panel with 8 lamps. Mounts to wall or stand.
• B343B4000: Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient.
• B343B40: Phototherapy Unit. UVB Narrowband. Single upright panel with Four 72" lamps. Mounts to wall or s
• B343B3200: Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient.
• B343B2400: Phototherapy Unit. UVB Narrowband. 4 connected panels, attached to a wall, wrap around patient.
• B343B20: Phototherapy Unit. UVB Narrow Band. Single upright Panel with Two 72" Lamps. Mounts to Wall.
• B343B1600: Phototherapy Unit. UVB Narrowband. 4 Connected Panels, attached to a wall, wrap around patient.
• B343B100: Phototherapy Unit. UVB Narrowband. Single upright panel with 10 lamps. Mounts to wall or to stan