Easy@Home Smart Basal Thermometer

GUDID 10810038631865

EASY HEALTHCARE CORPORATION

Natural conception assistance kit

• Primary Device ID: 10810038631865
• NIH Device Record Key: f40fc154-6a2c-4392-824f-d75d3eaceaa8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Smart Basal Thermometer
• Version Model Number: EBT-300 PURPLE
• 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: false
• 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	00810038631868 [Primary]
GS1	10810038631865 [Package]; Contains: 00810038631868; Package: [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160308

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: 2021-01-18
• Device Publish Date: 2021-01-10

On-Brand Devices [Easy@Home Smart Basal Thermometer]

• 10810038630196: EBT-300
• 10810038631063: EBT-300
• 10810038631865: EBT-300 PURPLE
• 10810038633708: EBT-089