Easy@Home OXY Single Drug Screen Test (10 tests kit)

GUDID 10855944007700

Easy@Home Single Drug Screen Test ; 10 tests kit; OXY

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 10855944007700
• NIH Device Record Key: 5cc8f476-39f6-4717-b7e8-5e7b169394c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home OXY Single Drug Screen Test (10 tests kit)
• Version Model Number: EDOX-114-10
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 10
• 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	00855944007703 [Primary]
GS1	10855944007700 [Package]; Contains: 00855944007703; Package: Carton [90 Units]; In Commercial Distribution
GS1	90855944007706 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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: 2019-08-12
• Device Publish Date: 2019-08-02

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