Easy@Home Pregnancy Test (10 HCG strips) EZW1-S-10

GUDID 10810038634491

10 tests kit; Pregnancy Test

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 10810038634491
• NIH Device Record Key: 7e34b94a-0668-41f5-8cf4-38749729b1f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Pregnancy Test (10 HCG strips)
• Version Model Number: EZW1-S
• Catalog Number: EZW1-S-10
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 10
• 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	00810038634494 [Primary]
GS1	10810038634491 [Package]; Contains: 00810038634494; Package: Carton [400 Units]; In Commercial Distribution
GS1	30810038634495 [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: 2
• Public Version Date: 2023-07-06
• Device Publish Date: 2023-01-09

On-Brand Devices [Easy@Home Pregnancy Test (10 HCG strips)]

• 10850253007779: 10 tests kit; HCG strips
• 10810038634491: 10 tests kit; Pregnancy Test