Easy@Home Digital Basal Thermometer

GUDID 00810038633213

EASY HEALTHCARE CORPORATION

Intermittent electronic patient thermometer

• Primary Device ID: 00810038633213
• NIH Device Record Key: e3ee9d2e-fef4-4a62-b6ce-aa2f1b5408dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Digital Basal Thermometer
• Version Model Number: EBT-018 PINK
• 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	00810038633213 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183393

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: 2022-05-18
• Device Publish Date: 2022-05-10

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

• 10810038630189: EBT-100
• 10850003180035: EBT100
• 10810038631605: EBT-100 PURPLE
• 10810038632534: EBT-018
• 00810038633213: EBT-018 PINK
• 00810038632698: EBT-018 PURPLE