easy@Home PdG Urine Test Strip EZW3-S-10

GUDID 10810038638048

easy@Home PdG Urine Test Strip (10 tests)

EASY HEALTHCARE CORPORATION

Natural conception assistance kit

• Primary Device ID: 10810038638048
• NIH Device Record Key: baaa86d9-1d2d-4f64-9c73-4d10e1101182
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: easy@Home PdG Urine Test Strip
• Version Model Number: EZW3-S
• Catalog Number: EZW3-S-10
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	00810038638041 [Primary]
GS1	10810038638048 [Package]; Contains: 00810038638041; Package: Carton [150 Units]; In Commercial Distribution
GS1	30810038638042 [Unit of Use]

FDA Product Code

• QKE: Immunoassay, Pregnanediol Glucuronide, 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: 2025-08-01
• Device Publish Date: 2025-07-24

On-Brand Devices [easy@Home PdG Urine Test Strip]

• 10810038638048: easy@Home PdG Urine Test Strip (10 tests)
• 10810038637157: easy@Home PdG Urine Test Strip (5 tests)