Easy@Home Pregnancy Test (20 HCG strips +20 cups) EZW-HCG20C20

GUDID 10810038634262

20 tests kit +20 cups; Pregnancy Test

EASY HEALTHCARE CORPORATION

Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

• Primary Device ID: 10810038634262
• NIH Device Record Key: c925e3a1-1c2c-4df0-b73a-6241ccffe9fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Pregnancy Test (20 HCG strips +20 cups)
• Version Model Number: EZW1-S
• Catalog Number: EZW-HCG20C20
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 20
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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	00810038634265 [Primary]
GS1	10810038634262 [Package]; Contains: 00810038634265; Package: Carton [150 Units]; In Commercial Distribution
GS1	30810038634266 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043443

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-06
• Device Publish Date: 2023-01-11

Devices Manufactured by EASY HEALTHCARE CORPORATION

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• 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