Easy@Home Pregnancy Test (3 tests) EZW1-MA-3

GUDID 10810038635702

Easy@Home Pregnancy Test (3 tests)

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 10810038635702
• NIH Device Record Key: 5920b242-74a2-40e6-811a-13f6aa2d2880
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Pregnancy Test (3 tests)
• Version Model Number: EZW1-MA
• Catalog Number: EZW1-MA-3
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 3
• 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	00810038635705 [Primary]
GS1	10810038635702 [Package]; Contains: 00810038635705; Package: [130 Units]; In Commercial Distribution
GS1	30810038635706 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230038

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-05
• Device Publish Date: 2024-01-26

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