Easy@Home Single Drug Screen Test (Marijuanan Urine Test) EDTH-114-12

GUDID 30810038633627

Easy@Home Single Drug Screen Test (Marijuanan Urine Test)- 12 tests kit

EASY HEALTHCARE CORPORATION

Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 30810038633627
• NIH Device Record Key: 66792913-3bff-4c43-946a-173286105e0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Single Drug Screen Test (Marijuanan Urine Test)
• Version Model Number: EDTH-114
• Catalog Number: EDTH-114-12
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 12
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810038633626 [Primary]
GS1	30810038633627 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161044

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

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: 2022-04-11
• Device Publish Date: 2022-04-01

Devices Manufactured by EASY HEALTHCARE CORPORATION

• 10810038636846 - Easy@Home Pregnancy Test (5 tests): 2024-11-18 Easy@Home Pregnancy Test (5 tests)
• 10810038636266 - Easy@Home Blood Pressure Monitor: 2024-11-12
• 10810038636990 - Areta Multi-Drug Test Cup (25 tests kit): 2024-10-08 Areta 5 Panel Drug Test Cup (25 Test Kit) - THC,COC,OPI2000,BZO,AMP
• 10810038636549 - Easy@Home Pregnancy Test: 2024-10-04 Easy@Home Pregnancy Test
• 40810038636434 - Easy@Home Multi-Drug Screen Test (5 tests kit): 2024-07-25 5 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
• 20810038636447 - Easy@Home Nicotine Urine Test (5 tests one kit): 2024-07-25 5 tests kit; Nicotine Urine Test -COT
• 10810038636488 - Premom Smart Basal Thermometer: 2024-05-20
• 10810038636129 - Easy@Home Adhesive Electrode Pads: 2024-04-23