Easy@Home COC Single Drug Screen Test (25 tests kit) EDCO-114-25

GUDID 10855944007625

25 tests kit; COC Single Panel

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10855944007625
• NIH Device Record Key: 0e38f085-989f-4cd8-bf3d-2f9e30080f76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home COC Single Drug Screen Test (25 tests kit)
• Version Model Number: EDCO-114
• Catalog Number: EDCO-114-25
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	00855944007628 [Primary]
GS1	10855944007625 [Package]; Contains: 00855944007628; Package: Carton [20 Units]; In Commercial Distribution
GS1	30855944007629 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• DIO: Enzyme Immunoassay, Cocaine And Cocaine 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: 2018-08-01
• Device Publish Date: 2018-07-01

On-Brand Devices [Easy@Home COC Single Drug Screen Test (25 tests kit)]

• 10855944007625: 25 tests kit; COC Single Panel
• 10810038631407: 25 tests kit; COC Single Panel