Easy@Home Nicotine Urine Test (5 tests one kit) ECOT-114-5

GUDID 20810038636447

5 tests kit; Nicotine Urine Test -COT

EASY HEALTHCARE CORPORATION

Cotinine IVD, kit, rapid ICT, clinical

• Primary Device ID: 20810038636447
• NIH Device Record Key: d7fbef04-8e0e-41a2-83f9-a86a7e20db08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Nicotine Urine Test (5 tests one kit)
• Version Model Number: ECOT-114
• Catalog Number: ECOT-114-5
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 5
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00810038636443 [Primary]
GS1	20810038636447 [Package]; Contains: 00810038636443; Package: CARTONS [12 Units]; In Commercial Distribution
GS1	40810038636441 [Unit of Use]

FDA Product Code

• MRS: Test System, Nicotine, Cotinine, Metabolites

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: 2024-07-25
• Device Publish Date: 2024-07-17

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