Easy@Home Fuel Cell Breathalyzer

GUDID 10850003180325

EASY HEALTHCARE CORPORATION

Alcohol breath analyser

• Primary Device ID: 10850003180325
• NIH Device Record Key: f4e63a44-14af-4d7f-bec4-36198796e5d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Fuel Cell Breathalyzer
• Version Model Number: EAT-05FL
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00850003180328 [Primary]
GS1	10850003180325 [Package]; Contains: 00850003180328; Package: Carton [40 Units]; In Commercial Distribution

FDA Product Code

• DJZ: Devices, Breath Trapping, Alcohol

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

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