Optim V

GUDID 00859424004190

Home Pregnancy Test

PHARMADEL INC

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

• Primary Device ID: 00859424004190
• NIH Device Record Key: 9d200588-932c-41b0-ad10-7d996bb60ae6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optim V
• Version Model Number: 00419
• Company DUNS: 030129680
• Company Name: PHARMADEL INC
• Device Count: 1
• 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	00859424004190 [Primary]

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: 2026-01-21
• Device Publish Date: 2026-01-13

On-Brand Devices [Optim V]

• 00899711001495: Home Pregnancy Test
• 00859424004190: Home Pregnancy Test