Easy@Home Pregnancy Test (3 tests) EZW1-MA-3

GUDID 10810038635702

Easy@Home Pregnancy Test (3 tests)

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 10810038635702
• NIH Device Record Key: 5920b242-74a2-40e6-811a-13f6aa2d2880
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Pregnancy Test (3 tests)
• Version Model Number: EZW1-MA
• Catalog Number: EZW1-MA-3
• 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: 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	00810038635705 [Primary]
GS1	10810038635702 [Package]; Contains: 00810038635705; Package: [130 Units]; In Commercial Distribution
GS1	30810038635706 [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

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