FDA UDI
In Commercial Distribution
🇺🇸 United States
FemCath
DI: 00859500005080
·
Model: CBC-150
·
FEMASYS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- FemCath
- Primary DI
- 00859500005080
- Version / Model
- CBC-150
- Catalog Number
- 04194
- Company Name
- FEMASYS INC.
- Labeler DUNS
- 147590330
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-06
- Public Version
- 2
- Public Version Date
- 2024-03-29
- Public Version Status
- Update
- Public Device Record Key
- 9c60260b-3853-4249-8df0-ffa00d5fefdd
Device Description
FemCath CBC-150 with VariLock and FemVue, 1 Pack
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34157 | Salpingographic catheter | A flexible, balloon-tipped tube inserted transvaginally and through the uterus for the selective catheterization/cannulation of the fallopian tubes, in order to inject dye or a contrast medium into the tubes for a radiographic procedure; it is usually radiopaque. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859500005080 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K100662 | 000 |