FemVue® Saline-Air Device FSA-200

GUDID 00859500005004

FEMASYS INC.

Uterine injector

• Primary Device ID: 00859500005004
• NIH Device Record Key: c75600e3-b9f8-40f3-87d6-f4a57337e4a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FemVue® Saline-Air Device
• Version Model Number: FSA-200
• Catalog Number: FSA-200
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00859500005004 [Primary]

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: 2019-03-20
• Device Publish Date: 2019-03-12

Devices Manufactured by FEMASYS INC.

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• 10859500005018 - FemaSeed: 2023-12-06 FemaSeed, Intratubal Insemination, 1 pack