FemSperm Analyzer

Basic Information

• Brand Name: FemSperm Analyzer
• Primary DI: 00859500005288
• Version / Model: FSP-500
• Catalog Number: 05447
• Company Name: FEMASYS INC.
• Labeler DUNS: 147590330
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-06
• Public Version: 1
• Public Version Date: 2026-02-16
• Public Version Status: New
• Public Device Record Key: 33c3d91e-b8fd-43b0-9d33-527309c8fa84

Device Description

FemSperm Sperm Analyzer Pack

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
POV	Semen Analysis Device	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57855	Spermatozoa/semen analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of a semen specimen to assess volume, spermatozoa concentration, motility and/or morphological characteristics.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859500005288	GS1

Premarket Submissions

Submission Number	Supplement Number
K243114	000