DUO+ 240 Treatment Head

GUDID B271LSB3000P0

DUO+ 240 Treatment Head (LS-B 3000+)

Meditech International Inc

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• Primary Device ID: B271LSB3000P0
• NIH Device Record Key: 1977b1a2-d0ea-4709-b0a6-2d57382e5dc8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUO+ 240 Treatment Head
• Version Model Number: LS-B 3000+
• Company DUNS: 255079485
• Company Name: Meditech International 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B271LSB3000P0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023621

FDA Product Code

• ILY: Lamp, Infrared, Therapeutic Heating

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: 2018-03-29
• Device Publish Date: 2018-02-01

On-Brand Devices [DUO+ 240 Treatment Head]

• B271LSB3000P0: DUO+ 240 Treatment Head (LS-B 3000+)
• B271DUO2400: DUO+ 240