FemCath 02827

GUDID 00859500005035

FemCath, Cornual Balloon Catheter, CBC-100 with StopLock, 1 Pack (tray)

FEMASYS INC.

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• Primary Device ID: 00859500005035
• NIH Device Record Key: fbb80972-e25d-4582-a616-fe5b57e0d379
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FemCath
• Version Model Number: CBC-100
• Catalog Number: 02827
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859500005035 [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: 2022-04-28
• Device Publish Date: 2022-04-20

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