FemaSeed

GUDID 00859500005011

FemaSeed, Intratubal Insemination, 2 pack

FEMASYS INC.

Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set Assisted reproduction transfer catheter/set

• Primary Device ID: 00859500005011
• NIH Device Record Key: 495ea80f-7b8d-49d1-80a2-ad7766019dfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FemaSeed
• Version Model Number: FDI-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	00859500005011 [Unit of Use]
GS1	20859500005015 [Primary]
GS1	30859500005012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231730

FDA Product Code

• MQF: Catheter, Assisted Reproduction

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: 2023-12-06
• Device Publish Date: 2023-11-28

On-Brand Devices [FemaSeed]

• 00859500005011: FemaSeed, Intratubal Insemination, 2 pack
• 10859500005018: FemaSeed, Intratubal Insemination, 1 pack
• 00859500005103: FemaSeed Intratubal Insemination, FDI-200, 5-Pack
• 10859500005100: FemaSeed, Intratubal Insemination, 1-Pack