Easy@Home Digital Basal Thermometer

GUDID 10810038630189

EASY HEALTHCARE CORPORATION

Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit Natural conception assistance kit

• Primary Device ID: 10810038630189
• NIH Device Record Key: 4348d00b-ae3d-40ad-b16a-23ad696ad371
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Digital Basal Thermometer
• Version Model Number: EBT-100
• 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	00810038630182 [Primary]
GS1	10810038630189 [Package]; Contains: 00810038630182; Package: Carton [200 Units]; In Commercial Distribution
GS1	20810038630186 [Package]; Contains: 00810038630182; Package: Carton [160 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122912

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: 2020-02-11
• Device Publish Date: 2020-02-03

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