FemSperm No Analysis 05550

GUDID 00859500005356

FemSperm Convenience Pack No Analysis (2-Pack)

FEMASYS INC.

IVF medium

• Primary Device ID: 00859500005356
• NIH Device Record Key: 00171877-13bc-45be-bbf7-a95d9f809632
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FemSperm No Analysis
• Version Model Number: FSP-403
• Catalog Number: 05550
• 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	00859500005356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023222

FDA Product Code

• MQL: Media, Reproductive

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 No Analysis]

• 00859500005356: FemSperm Convenience Pack No Analysis (2-Pack)
• 00859500005325: FemSperm Convenience Pack No Analysis (5-Pack)