FemCath 03207

GUDID 00859500005080

FemCath CBC-150 with VariLock and FemVue, 1 Pack

FEMASYS INC.

Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter Salpingographic catheter

• Primary Device ID: 00859500005080
• NIH Device Record Key: 9c60260b-3853-4249-8df0-ffa00d5fefdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FemCath
• Version Model Number: CBC-150
• Catalog Number: 03207
• 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	00859500005080 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100662

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: 2023-06-14
• Device Publish Date: 2023-06-06

On-Brand Devices [FemCath]

• 00859500005035: FemCath, Cornual Balloon Catheter, CBC-100 with StopLock, 1 Pack (tray)
• 00859500005080: FemCath CBC-150 with VariLock and FemVue, 1 Pack
• 00859500005042: CBC-1501, Bulk, Sterile