Easy@Home Multi-Drug Screen Test (2 tests kit)

GUDID 10850253007410

2 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 10850253007410
• NIH Device Record Key: 339d3746-d69d-4b80-b903-8e6e34a41391
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Multi-Drug Screen Test (2 tests kit)
• Version Model Number: EDOAP-3104
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 2
• 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	00850253007413 [Primary]
GS1	10850253007410 [Package]; Contains: 00850253007413; Package: [180 Units]; In Commercial Distribution
GS1	30850253007414 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-12
• Device Publish Date: 2016-09-15

On-Brand Devices [Easy@Home Multi-Drug Screen Test (2 tests kit)]

• 10850253007939: 2 tests kit;12-Panel Dip Card;BUP/THC/COC/MOP/MET/OXY/AMP/BAR/BZO/MTD/MDMA/PCP
• 10850253007472: 2 tests kit;12-Panel Dip Card;AMP-COC/OXY-THC/OPI/MET/BZO/MDMA/MTD/BAR/PCP/PPX
• 10850253007410: 2 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA
• 10850253007359: 2 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC