FemVue® Saline-Air Device

Basic Information

• Brand Name: FemVue® Saline-Air Device
• Primary DI: 00859500005004
• Version / Model: FSA-200
• Catalog Number: FSA-200
• Company Name: FEMASYS INC.
• Labeler DUNS: 147590330
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-12
• Public Version: 1
• Public Version Date: 2019-03-20
• Public Version Status: New
• Public Device Record Key: c75600e3-b9f8-40f3-87d6-f4a57337e4a7

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKF	Cannula, Manipulator/Injector, Uterine	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
15622	Uterine injector	A hand-held manual device designed to inject/administer liquids into the uterus and/or fallopian tubes, typically contrast medium during radiographic procedures to evaluate tubal patency. It is typically used in conjunction with an appropriate intrauterine catheter which may be manipulated through an external mechanism. The injector may be used to manipulate or reposition the uterus during diagnostic and/or surgical procedures. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859500005004	GS1

Premarket Submissions

Submission Number	Supplement Number
K110288	000