Easy@Home Multi-Drug Screen Test (5 tests kit)

GUDID 10850253007489

5 tests kit;12-Panel Dip Card;AMP-COC/OXY-THC/OPI/MET/BZO/MDMA/MTD/BAR/PCP/PPX

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 10850253007489
• NIH Device Record Key: 5bfb7980-ae69-48d3-93e7-d483596dc297
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Multi-Drug Screen Test (5 tests kit)
• Version Model Number: EDOAP-1124
• 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	00850253007482 [Primary]
GS1	10850253007489 [Package]; Contains: 00850253007482; Package: [90 Units]; In Commercial Distribution
GS1	30850253007483 [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 Screen Test (5 tests kit)]

• 10850253007960: 5 tests kit;6-Panel Dip Card; THC/COC/OPI/AMP/MET/BZO
• 10850253007878: 5 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
• 10850253007489: 5 tests kit;12-Panel Dip Card;AMP-COC/OXY-THC/OPI/MET/BZO/MDMA/MTD/BAR/PCP/PPX
• 10850253007427: 5 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA
• 10850253007366: 5 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
• 10850253007342: 5 tests kit;5-Panel Dip Card;THC/COC/OPI/AMP/MET
• 30810038630589: 5 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
• 30810038630572: 5 tests kit;5-Panel Dip Card;THC/COC/OPI/AMP/MET
• 10810038630509: 5 tests kit;6-Panel Dip Card; THC/COC/OPI/AMP/MET/BZO
• 40810038636434: 5 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC