FDA UDI
In Commercial Distribution
🇺🇸 United States
YO Home Sperm Test
DI: 07290016650587
·
Model: YO Universal 2.0 packed kit for BirdandBe - 2 tests
·
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- YO Home Sperm Test
- Primary DI
- 07290016650587
- Version / Model
- YO Universal 2.0 packed kit for BirdandBe - 2 tests
- Catalog Number
- YO-FA-01912-00
- Company Name
- M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
- Labeler DUNS
- 514680529
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-01
- Public Version
- 1
- Public Version Date
- 2023-01-09
- Public Version Status
- New
- Public Device Record Key
- 985fdae3-5477-4b57-bae9-f905af529cbb
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| POV | Semen Analysis Device | Hematology | 864.5220 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61920 | Motile sperm concentration IVD, kit, imaging, self-testing | A collection of devices intended to be used to visualize sperm and calculate motile sperm concentration in a semen specimen for the assessment of male fertility. It includes a magnifying lens and application software. The lens is intended to be attached to a compatible mobile communication device with a camera (not included) which runs the software to enable visualization and analysis of sperm in the semen specimen. It also includes materials to collect, process, and display the semen specimen. It is available [non-prescription] over-the-counter (OTC) for use in the home. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016650587 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161493 | 000 |