FemVue

GUDID 20859500005008

FemVue Saline-Air Device FSA-200 2-pack

FEMASYS INC.

Uterine injector

• Primary Device ID: 20859500005008
• NIH Device Record Key: 89a67438-1a11-4a6e-9d03-c568ff768678
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FemVue
• Version Model Number: FSA-200
• Company DUNS: 147590330
• Company Name: FEMASYS INC.
• Device Count: 2
• 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: 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	20859500005008 [Primary]
GS1	40859500005002 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110288

FDA Product Code

• LKF: Cannula, Manipulator/Injector, Uterine

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: 2026-01-14
• Device Publish Date: 2026-01-06

On-Brand Devices [FemVue]

• 30859500005005: FemVue Saline-Air Device FSA-200 (5-Pack)
• 20859500005008: FemVue Saline-Air Device FSA-200 2-pack