FDA UDI
In Commercial Distribution
🇺🇸 United States
FemSperm Pack Analysis
DI: 00859500005349
·
Model: FSP-402
·
FEMASYS INC.
Product Codes
2
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FemSperm Pack Analysis
- Primary DI
- 00859500005349
- Version / Model
- FSP-402
- Catalog Number
- 05549
- Company Name
- FEMASYS INC.
- Labeler DUNS
- 147590330
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-06
- Public Version
- 1
- Public Version Date
- 2026-02-16
- Public Version Status
- New
- Public Device Record Key
- 146a908c-93fa-4441-933f-75ee9b04eb46
Device Description
FemSperm Convenience Pack With Analysis (2-Pack)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| POV | Semen Analysis Device | Hematology | 864.5220 | 2 |
| MQL | Media, Reproductive | Obstetrics/Gynecology | 884.6180 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44046 | IVF medium | A solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device. | No | Active |
| 57855 | Spermatozoa/semen analyser IVD | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of a semen specimen to assess volume, spermatozoa concentration, motility and/or morphological characteristics. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859500005349 | GS1 |