Easy@Home Pregnancy Test Midstream (20 tests kit) EZW1-M

GUDID 10850253007816

20 tests kit; HCG Midstreams

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 10850253007816
• NIH Device Record Key: c01a443c-0823-410f-b696-b0e69ba5078f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Pregnancy Test Midstream (20 tests kit)
• Version Model Number: EZM1-H20
• Catalog Number: EZW1-M
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 20
• 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	00850253007819 [Primary]
GS1	10850253007816 [Package]; Contains: 00850253007819; Package: Carton [56 Units]; In Commercial Distribution
GS1	30850253007810 [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: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-23

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