Easy@Home Multi-Drug Test Cup (25 tests kit)

GUDID 10850253007601

25 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: 10850253007601
• NIH Device Record Key: 02a064b6-15ec-4a97-b7ae-0cb4ce0d6255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Multi-Drug Test Cup (25 tests kit)
• Version Model Number: ECDOA-1144A3
• 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	00850253007604 [Primary]
GS1	10850253007601 [Package]; Contains: 00850253007604; Package: [4 Units]; In Commercial Distribution
GS1	30850253007605 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• JXN: Enzyme Immunoassay, Propoxyphene

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 Test Cup (25 tests kit)]

• 10850253007601: 25 tests kit;14-Panel T-Cup 3-AD; COC/THC/OPI/BZO/MET/TCA/OXY/BUP/BAR/MTD/AMP/MDMA/PCP/PPX)OX/SG
• 10850253007588: 25 tests kit;12 Panel-T cup; AMP/BAR/BZO/BUP/COC/MDMA/MET/MTD/MOP/OXY/THC/PCP
• 10850253007564: 25 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
• 10850253007540: 25 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET
• 10810038631353: 25 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
• 10810038631339: 25 tests kit;14-Panel T-Cup 3-AD; COC/THC/OPI/BZO/MET/TCA/OXY/BUP/BAR/MTD/AMP/MDMA/PCP/PPX)OX/SG