Vivoo

GUDID 20860011489164

At-Home Ovulation Test

VIVOSENS INC.

Natural conception assistance kit

• Primary Device ID: 20860011489164
• NIH Device Record Key: 31a94bd7-fbb4-4c5a-a24e-80d4b0225b22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vivoo
• Version Model Number: VWHL50-v2
• Company DUNS: 086601609
• Company Name: VIVOSENS INC.
• Device Count: 50
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00860014219078 [Primary]
GS1	00860014219085 [Primary]
GS1	20860011489164 [Unit of Use]

FDA Product Code

• NGE: Test, Luteinizing Hormone (Lh), 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: 2025-12-08
• Device Publish Date: 2025-11-28

On-Brand Devices [Vivoo]

• 10860011489167: 5-Strip HCG Pregnancy Tests, 25-Strip LH-Ovulation Test, and 30 Plastic Urine Cups
• 10860011489150: Vivoo FSH Fertility Test (Urine), with 10 products inside.
• 20860011489164: At-Home Ovulation Test