Easy@Home Pregnancy Test Strip (40 tests kit)

GUDID 10850253007847

40 tests kit; HCG strips

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 10850253007847
• NIH Device Record Key: fd444b71-5346-4778-aecc-99218f065c1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Pregnancy Test Strip (40 tests kit)
• Version Model Number: EZW1-S
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 40
• 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	00850253007840 [Primary]
GS1	10850253007847 [Package]; Contains: 00850253007840; Package: Carton [120 Units]; In Commercial Distribution
GS1	20850253007844 [Package]; Contains: 00850253007840; Package: Carton [80 Units]; In Commercial Distribution
GS1	30850253007841 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043443

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-23

On-Brand Devices [Easy@Home Pregnancy Test Strip (40 tests kit)]

• 10850253007847: 40 tests kit; HCG strips
• 10810038630370: 40 tests kit; HCG strips