Easy@Home Digital Thermometer

GUDID 10810038631582

EASY HEALTHCARE CORPORATION

Intermittent electronic patient thermometer

• Primary Device ID: 10810038631582
• NIH Device Record Key: 7a9546f9-5a14-4109-8147-bbe2a8d64fab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Digital Thermometer
• Version Model Number: EMT-A12
• 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	00810038631585 [Primary]
GS1	10810038631582 [Package]; Contains: 00810038631585; Package: [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101387

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: 2020-11-03
• Device Publish Date: 2020-10-26

On-Brand Devices [Easy@Home Digital Thermometer]

• 00850253007208: EMT-026
• 20810038630230: EMT-026
• 10810038630820: EMT-021 Grey
• 20810038630810: EMT-021 Yellow
• 10810038630790: EMT-021 Green
• 10810038631582: EMT-A12