FemSperm Analyzer 05447

GUDID 00859500005288

FemSperm Sperm Analyzer Pack

FEMASYS INC.

Spermatozoa/semen analyser IVD

• Primary Device ID: 00859500005288
• NIH Device Record Key: 33c3d91e-b8fd-43b0-9d33-527309c8fa84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FemSperm Analyzer
• Version Model Number: FSP-500
• Catalog Number: 05447
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	00859500005288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243114

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

Devices Manufactured by FEMASYS INC.

• 00859500005288 - FemSperm Analyzer: 2026-02-16FemSperm Sperm Analyzer Pack
• 00859500005288 - FemSperm Analyzer: 2026-02-16 FemSperm Sperm Analyzer Pack
• 00859500005318 - FemSperm Pack Analysis: 2026-02-16 FemSperm Convenience Pack With Analysis (5-Pack)
• 00859500005325 - FemSperm No Analysis: 2026-02-16 FemSperm Convenience Pack No Analysis (5-Pack)
• 00859500005349 - FemSperm Pack Analysis: 2026-02-16 FemSperm Convenience Pack With Analysis (2-Pack)
• 00859500005356 - FemSperm No Analysis: 2026-02-16 FemSperm Convenience Pack No Analysis (2-Pack)
• 20859500005008 - FemVue: 2026-01-14 FemVue Saline-Air Device FSA-200 2-pack
• 30859500005005 - FemVue: 2026-01-14 FemVue Saline-Air Device FSA-200 (5-Pack)
• 10859500005162 - StopLock: 2025-05-12 StopLock Balloon Inflation Syringe 1-Pack , SLK-100