DUOFLEX+ 180 Treatment Head

GUDID B271LSB48900

DUOFLEX+ 180 Treatment Head

Meditech International Inc

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• Primary Device ID: B271LSB48900
• NIH Device Record Key: 55b51dde-85d4-4693-b917-bb66ad3e4010
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DUOFLEX+ 180 Treatment Head
• Version Model Number: LS-B 4890
• 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	B271LSB48900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051875

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

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