Easy@Home Multi-Drug Screen Test (15 tests kit) EDOAP-264-15

GUDID 00850253007970

15 tests kit; 6-Panel Dip Card; THC/COC/OPI/AMP/MET/BZO

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 00850253007970
• NIH Device Record Key: 9e726b41-7e65-4729-83b3-f0a27d850b3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Multi-Drug Screen Test (15 tests kit)
• Version Model Number: EDOAP-264
• Catalog Number: EDOAP-264-15
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 15
• 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	00850253007970 [Primary]
GS1	10850253007977 [Package]; Package: Carton [45 Units]; In Commercial Distribution
GS1	30850253007971 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-12
• Device Publish Date: 2018-07-01

On-Brand Devices [Easy@Home Multi-Drug Screen Test (15 tests kit)]

• 00850253007970: 15 tests kit; 6-Panel Dip Card; THC/COC/OPI/AMP/MET/BZO
• 10850253007892: 15 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
• 10850253007502: 15 tests kit;12-Panel Dip Card;AMP-COC/OXY-THC/OPI/MET/BZO/MDMA/MTD/BAR/PCP/PPX
• 10850253007458: 15 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA
• 10850253007373: 15 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
• 10850253007328: 15 tests kit ;5-Panel Dip Card;THC/COC/OPI/AMP/MET