FemVue® Saline-Air Device FSA-200
GUDID 00859500005004
FEMASYS INC.
Uterine injector| Primary Device ID | 00859500005004 |
| NIH Device Record Key | c75600e3-b9f8-40f3-87d6-f4a57337e4a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FemVue® Saline-Air Device |
| Version Model Number | FSA-200 |
| Catalog Number | FSA-200 |
| 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 | 00859500005004 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110288
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 | 2019-03-20 |
| Device Publish Date | 2019-03-12 |
Devices Manufactured by FEMASYS INC.
| 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 |
| 00859500005080 - FemCath | 2023-06-14 FemCath CBC-150 with VariLock and FemVue, 1 Pack |
Trademark Results [FemVue]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FEMVUE 77914748 4109348 Live/Registered |
FEMASYS INC. 2010-01-19 |
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