FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sapyen At-Home Male Fertility Analysis Kit
DI: 09309000599004
·
Model: 1
·
VITO HEALTH PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sapyen At-Home Male Fertility Analysis Kit
- Primary DI
- 09309000599004
- Version / Model
- 1
- Catalog Number
- 1
- Company Name
- VITO HEALTH PTY LTD
- Labeler DUNS
- 750355719
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-13
- Public Version
- 2
- Public Version Date
- 2024-01-01
- Public Version Status
- Update
- Public Device Record Key
- b94b1444-0690-449b-9798-05f1dee05459
- Distribution End Date
- 2024-01-01
Device Description
Sapyen At-Home Male Fertility Analysis Kit - At-home male fertility diagnostic kit, which enables customers to collect semen samples from the comfort of their own home without having to rush out the door to drop their sample to the nearest testing centre. Our kit extends the shelf life of sperm, so customers can send their sample via normal postal services to accredited labs for semen analysis. After the analysis, customers receive a comprehensive report explaining the results on each of their parameters and providing recommendations that consider their health history.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| KDT | Container, Specimen Mailer And Storage, Sterile | Pathology | 864.3250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66354 | Home semen collection kit IVD | A collection of in vitro diagnostic devices and materials intended to be used by a layperson in the home to collect a semen specimen for subsequent in vitro diagnostic investigations (e.g., fertility testing). The kit typically includes a covered specimen receptacle with a preservative, a pipette, instructions for use, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 09309000599004 | GS1 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store between 2 and 8 degrees celsius prior to use.