Areta Cotinine Test Strip -COT(10 tests one kit) ASCOT-114-10C10

GUDID 30810038634655

10 tests kit; COT Single Drug Screen Test

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 30810038634655
• NIH Device Record Key: 50f15820-c6a6-4d7a-ba52-1dcfca35d3f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Areta Cotinine Test Strip -COT(10 tests one kit)
• Version Model Number: ASCOT-114C
• Catalog Number: ASCOT-114-10C10
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 10
• 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	00810038634654 [Primary]
GS1	10810038634651 [Package]; Contains: 00810038634654; Package: carton [56 Units]; In Commercial Distribution
GS1	30810038634655 [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: 2023-07-27
• Device Publish Date: 2023-07-19

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• 30810038634655 - Areta Cotinine Test Strip -COT(10 tests one kit): 2023-07-27 10 tests kit; COT Single Drug Screen Test