Easy@Home Multi-Drug Test Cup (5 tests kit) ECDOA-1144A3-5

GUDID 10810038631346

5 tests kit;14-Panel T-Cup 3-AD; COC/THC/OPI/BZO/MET/TCA/OXY/BUP/BAR/MTD/AMP/MDMA/PCP/PPX+OX/SG/PH

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 10810038631346
• NIH Device Record Key: de79203c-cf7c-4d31-87af-0ec806deabcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Multi-Drug Test Cup (5 tests kit)
• Version Model Number: ECDOA-1144A3
• Catalog Number: ECDOA-1144A3-5
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 5
• 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	00810038631349 [Primary]
GS1	10810038631346 [Package]; Contains: 00810038631349; Package: Carton [16 Units]; In Commercial Distribution
GS1	30810038631340 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-07
• Device Publish Date: 2020-06-29

On-Brand Devices [Easy@Home Multi-Drug Test Cup (5 tests kit)]

• 10850253007595: 5 tests kit;14-Panel T-Cup 3-AD; COC/THC/OPI/BZO/MET/TCA/OXY/BUP/BAR/MTD/AMP/MDMA/PCP/PPX+OX/SG/
• 10850253007571: 5 tests kit;12 Panel-T cup; AMP/BAR/BZO/BUP/COC/MDMA/MET/MTD/MOP/OXY/THC/PCP
• 10850253007557: 5 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
• 10850253007533: 5 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET
• 30810038631364: 5 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
• 10810038631346: 5 tests kit;14-Panel T-Cup 3-AD; COC/THC/OPI/BZO/MET/TCA/OXY/BUP/BAR/MTD/AMP/MDMA/PCP/PPX+OX/SG/
• 30810038631111: 5 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET