FemSperm Pack Analysis 05549

GUDID 00859500005349

FemSperm Convenience Pack With Analysis (2-Pack)

FEMASYS INC.

Spermatozoa/semen analyser IVD

• Primary Device ID: 00859500005349
• NIH Device Record Key: 146a908c-93fa-4441-933f-75ee9b04eb46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FemSperm Pack Analysis
• Version Model Number: FSP-402
• Catalog Number: 05549
• Company DUNS: 147590330
• Company Name: FEMASYS 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859500005349 [Primary]

FDA Product Code

• POV: Semen Analysis Device

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-16
• Device Publish Date: 2026-02-06

On-Brand Devices [FemSperm Pack Analysis]

• 00859500005349: FemSperm Convenience Pack With Analysis (2-Pack)
• 00859500005318: FemSperm Convenience Pack With Analysis (5-Pack)