Easy@Home Digital Basal Thermometer

GUDID 10850003180035

EASY HEALTHCARE CORPORATION

Natural conception assistance kit

• Primary Device ID: 10850003180035
• NIH Device Record Key: d856e379-d694-4701-9c77-f9c7b015920c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Digital Basal Thermometer
• Version Model Number: EBT100
• 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: false
• Serial Number: true
• 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	00850003180038 [Primary]
GS1	10850003180035 [Package]; Contains: 00850003180038; Package: Carton [200 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: 2019-08-08
• Device Publish Date: 2019-07-31

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