Easy@Home Pregnancy Test (20 HCG strips) EZW1-S-20

GUDID 30810038630268

20 tests kit; HCG strips

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 30810038630268
• NIH Device Record Key: f4b315f7-632c-4032-a799-d24087fabb9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Pregnancy Test (20 HCG strips)
• Version Model Number: EZW1-S
• Catalog Number: EZW1-S-20
• 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	00810038630267 [Primary]
GS1	30810038630268 [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: 2020-07-06
• Device Publish Date: 2020-06-26

On-Brand Devices [Easy@Home Pregnancy Test (20 HCG strips)]

• 10850253007694: 20 tests kit; HCG strips
• 30810038630268: 20 tests kit; HCG strips