Premom Smart Basal Thermometer

GUDID 10810038636488

EASY HEALTHCARE CORPORATION

Intermittent electronic patient thermometer

• Primary Device ID: 10810038636488
• NIH Device Record Key: cb70c322-59c1-465a-80c5-843f77636a33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premom Smart Basal Thermometer
• Version Model Number: EBT-380
• 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	00810038636481 [Primary]
GS1	10810038636488 [Package]; Contains: 00810038636481; Package: [80 Units]; In Commercial Distribution
GS1	20810038636485 [Package]; Contains: 00810038636481; Package: [10 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: 2024-05-20
• Device Publish Date: 2024-05-11

On-Brand Devices [Premom Smart Basal Thermometer]

• 10810038633777: EBT-380
• 10810038636488: EBT-380
• 00810038638973: EBT-380
• 00810038638928: EBT-380