Easy@Home Pregnancy Test (5 tests) EZW1-MA-5

GUDID 10810038635719

Easy@Home Pregnancy Test (5 tests)

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 10810038635719
• NIH Device Record Key: 5b75add5-9799-4cfe-a230-a6c3a4f4c503
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Pregnancy Test (5 tests)
• Version Model Number: EZW1-MA
• Catalog Number: EZW1-MA-5
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 5
• 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	00810038635712 [Primary]
GS1	10810038635719 [Package]; Contains: 00810038635712; Package: [130 Units]; In Commercial Distribution
GS1	30810038635713 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230038

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: 2024-02-05
• Device Publish Date: 2024-01-26

On-Brand Devices [Easy@Home Pregnancy Test (5 tests) ]

• 10810038635719: Easy@Home Pregnancy Test (5 tests)
• 10810038636846: Easy@Home Pregnancy Test (5 tests)