Easy@Home Pregnancy Test (100 HCG strips) EZW1-S-100

GUDID 10810038634507

100 tests kit; Pregnancy Test

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 10810038634507
• NIH Device Record Key: b4fe9ffb-2c0a-494a-92b0-8fff6cc69f7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Pregnancy Test (100 HCG strips)
• Version Model Number: EZW1-S
• Catalog Number: EZW1-S-100
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 100
• 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	00810038634500 [Primary]
GS1	10810038634507 [Package]; Contains: 00810038634500; Package: Carton [40 Units]; In Commercial Distribution
GS1	30810038634501 [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

• 10810038636129 - Easy@Home Adhesive Electrode Pads: 2024-04-23
• 10810038636051 - Premom Ovulation Tests (25 LH strips + 5 HCG strips): 2024-03-08 Premom Ovulation Tests (25 LH strips + 5 HCG strips)
• 10810038635702 - Easy@Home Pregnancy Test (3 tests): 2024-02-05 Easy@Home Pregnancy Test (3 tests)
• 10810038635719 - Easy@Home Pregnancy Test (5 tests): 2024-02-05 Easy@Home Pregnancy Test (5 tests)
• 10810038636044 - Easy@Home TENS AND MUSCLE STIMULATOR: 2024-01-29
• 30810038634754 - Easy@home Feminine Vaginal pH Test Strip(30 tests): 2023-08-10 Easy@home Feminine Vaginal pH Test Strip(30 tests)
• 30810038634761 - Easy@home Feminine Vaginal pH Test Strip(10 tests): 2023-08-10 Easy@home Feminine Vaginal pH Test Strip(10 tests)
• 30810038634655 - Areta Cotinine Test Strip -COT(10 tests one kit): 2023-07-27 10 tests kit; COT Single Drug Screen Test