Premom Pregnancy Test Strip (25 tests)

GUDID 10850003180066

Premom Pregnancy Test Strip ; 25 tests; Kit

EASY HEALTHCARE CORPORATION

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid 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: 10850003180066
• NIH Device Record Key: b9c1d0df-3413-499b-a128-6198634e8f4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premom Pregnancy Test Strip (25 tests)
• Version Model Number: PMS-125
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 25
• 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	00850003180069 [Primary]
GS1	10850003180066 [Package]; Contains: 00850003180069; Package: Carton [120 Units]; In Commercial Distribution
GS1	90850003180062 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103574

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: 2019-08-09
• Device Publish Date: 2019-08-01

Devices Manufactured by EASY HEALTHCARE CORPORATION

• 10810038636488 - Premom Smart Basal Thermometer: 2024-05-20
• 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)