Easy@Home Non-contact Infrared Thermometer

GUDID 00850253007154

EASY HEALTHCARE CORPORATION

Infrared patient thermometer, skin

• Primary Device ID: 00850253007154
• NIH Device Record Key: e704742e-43f9-4708-8cf3-6b7bc64aa3b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Non-contact Infrared Thermometer
• Version Model Number: NCT-301
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE 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: true
• Serial Number: false
• 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	00850253007154 [Primary]
GS1	10850253007151 [Package]; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130231

FDA Product Code

• FLL: Thermometer, Electronic, Clinical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-26
• Device Publish Date: 2016-08-05

On-Brand Devices [Easy@Home Non-contact Infrared Thermometer]

• 00850253007154: NCT-301
• 00810038630212: Non-contact Infrared Thermometer
• 10810038630806: Non-contact Infrared Thermometer