Easy@Home Ovulation Test Strip (50 tests-bulk pack)

GUDID 10810038630134

50 tests kit; LH test strips in bulk package

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 10810038630134
• NIH Device Record Key: ef357e57-c16a-4c98-b172-d7d3bab2c05b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Ovulation Test Strip (50 tests-bulk pack)
• Version Model Number: EZW2-S
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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	00810038630137 [Primary]
GS1	10810038630134 [Package]; Contains: 00810038630137; Package: Carton [60 Units]; In Commercial Distribution
GS1	90810038630130 [Unit of Use]

FDA Product Code

• CEP: Radioimmunoassay, Luteinizing Hormone

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: 2020-02-11
• Device Publish Date: 2020-02-03

On-Brand Devices [Easy@Home Ovulation Test Strip (50 tests-bulk pack)]

• 10850253007830: 50 tests kit; LH test strips in bulk package
• 10810038630134: 50 tests kit; LH test strips in bulk package