Easy@Home Pregnancy Test (3 HCG Midstreams) EZM1-H3

GUDID 10855944007243

Easy@Home 3 Pregnancy Test Sticks

EASY HEALTHCARE CORPORATION

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10855944007243
• NIH Device Record Key: 24b4161e-92d2-4ac0-b5e7-31c9c3d0679c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Pregnancy Test (3 HCG Midstreams)
• Version Model Number: EZW1-M
• Catalog Number: EZM1-H3
• 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: 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	00855944007246 [Primary]
GS1	10855944007243 [Package]; Contains: 00855944007246; Package: Carton [84 Units]; In Commercial Distribution
GS1	20855944007240 [Package]; Contains: 00855944007246; Package: Carton [70 Units]; In Commercial Distribution
GS1	30855944007247 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-01
• Device Publish Date: 2018-07-01

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