Non-contact Infrared Thermometer DT-100 00885

GUDID 18800003445537

The DT-100 non-contact infrared thermometer is intended to be used to measure temperature for consumers including adult, pediatric and neonatal using

Mediana.CO.LTD

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• Primary Device ID: 18800003445537
• NIH Device Record Key: 47d050f2-5fc7-4bdb-b730-f7412a2e9421
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Non-contact Infrared Thermometer DT-100
• Version Model Number: DT-100
• Catalog Number: 00885
• Company DUNS: 687879726
• Company Name: Mediana.CO.LTD
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	18800003445537 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160358

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

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: 2018-08-03
• Device Publish Date: 2018-07-03

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