FemChec
GUDID 00859500005097
FemChec Controlled Saline-Air Device, FCD-250 Bulk Sterile
FEMASYS INC.
Uterine injector| Primary Device ID | 00859500005097 |
| NIH Device Record Key | 433aaeb5-2159-412e-8227-29d722d4692f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FemChec |
| Version Model Number | FCD-250 |
| 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 | 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 | 00859500005097 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K241693
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 | 2024-09-24 |
| Device Publish Date | 2024-09-16 |
Devices Manufactured by FEMASYS INC.
| 00859500005097 - FemChec | 2024-09-24FemChec Controlled Saline-Air Device, FCD-250 Bulk Sterile |
| 00859500005097 - FemChec | 2024-09-24 FemChec Controlled Saline-Air Device, FCD-250 Bulk Sterile |
| 00859500005127 - VariLock | 2024-03-21 VariLock Balloon Inflation Syringe 3mL, Bulk Sterile |
| 10859500005100 - FemaSeed | 2024-01-04 FemaSeed, Intratubal Insemination, 1-Pack |
| 00859500005103 - FemaSeed | 2024-01-04 FemaSeed Intratubal Insemination, FDI-200, 5-Pack |
| 10859500005018 - FemaSeed | 2023-12-06 FemaSeed, Intratubal Insemination, 1 pack |
| 00859500005011 - FemaSeed | 2023-12-06 FemaSeed, Intratubal Insemination, 2 pack |
| 00859500005042 - FemCath | 2023-06-14 CBC-1501, Bulk, Sterile |
| 00859500005073 - VariLock | 2023-06-14 VariLock Balloon Inflation Syringe, Bulk Sterile |
Trademark Results [FemChec]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FEMCHEC 85124878 4422236 Live/Registered |
FEMASYS INC. 2010-09-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.