Easy@Home Pregnancy Test (60 HCG strips) EZW1-S-60

GUDID 10810038631971

60 tests per kit; HCG strips

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 10810038631971
• NIH Device Record Key: ef27a3c6-5312-4b5d-9713-a3ea86e37778
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Pregnancy Test (60 HCG strips)
• Version Model Number: EZW1-S
• Catalog Number: EZW1-S-60
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 60
• 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	00810038631974 [Primary]
GS1	10810038631971 [Package]; Contains: 00810038631974; Package: Carton [60 Units]; In Commercial Distribution
GS1	30810038631975 [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: 2022-02-25
• Device Publish Date: 2022-02-17

On-Brand Devices [Easy@Home Pregnancy Test (60 HCG strips)]

• 10850253007717: 60 tests kit; HCG strips
• 10810038631971: 60 tests per kit; HCG strips