Easy@Home Multi-Drug Screen Test (5 tests kit) EDOAP-264-5

GUDID 10810038630509

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

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 10810038630509
• NIH Device Record Key: 6d72d044-a006-4b3b-ad88-0f73c22a4082
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Multi-Drug Screen Test (5 tests kit)
• Version Model Number: EDOAP-264
• Catalog Number: EDOAP-264-5
• 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	00810038630502 [Primary]
GS1	10810038630509 [Package]; Contains: 00810038630502; Package: Carton [90 Units]; In Commercial Distribution
GS1	30810038630503 [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 Screen Test (5 tests kit)]

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• 10850253007427: 5 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA
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• 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