Easy@Home Rectal Digital Thermometer

GUDID 10810038632053

EASY HEALTHCARE CORPORATION

Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer Intermittent electronic patient thermometer

• Primary Device ID: 10810038632053
• NIH Device Record Key: 8c16d3b0-4718-457f-9947-4ca1b9841899
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Rectal Digital Thermometer
• Version Model Number: EMT-027
• 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	00810038632056 [Primary]
GS1	10810038632053 [Package]; Contains: 00810038632056; Package: [200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163518

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: 2021-10-28
• Device Publish Date: 2021-10-20

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