Easy@Home Pregnancy Test Strip

GUDID 00855944007062

Easy@Home Pregnancy Test Strip (Bulk)

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: 00855944007062
• NIH Device Record Key: b5489eff-4456-45fe-bd56-794bfd8c2e06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Pregnancy Test Strip
• Version Model Number: EZW1-S
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 1
• 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	00855944007062 [Primary]
GS1	10855944007069 [Package]; Package: Carton [2500 Units]; In Commercial Distribution
GS1	20855944007066 [Package]; Package: Carton [5000 Units]; In Commercial Distribution
GS1	30855944007063 [Package]; Package: Carton [7000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043443

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: 2018-08-01
• Device Publish Date: 2018-07-01

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