FDA UDI
In Commercial Distribution
🇺🇸 United States
SpermAlign
DI: 15070002516207
·
Model: CYT 001
·
CYTOSWIM LTD
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- SpermAlign
- Primary DI
- 15070002516207
- Version / Model
- CYT 001
- Company Name
- CYTOSWIM LTD
- Labeler DUNS
- 224735036
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-03-03
- Public Version
- 1
- Public Version Date
- 2025-03-11
- Public Version Status
- New
- Public Device Record Key
- 479f8741-440d-4d4d-a321-42afb0c742bc
Device Description
SpermAlign is a passive microfluidic device that separates sperm based on their motility. Separation is achieved through a defined microstructure which guides the motile sperm to the central collection outlet isolating it from the remaining sample. The device utilises a total processing volume of 180ul of liquefied semen added in 30ul aliquots to each of the six outer wells and with media added to the central well. Following incubation for 30 minutes, the concentrated motile sperm is withdrawn from the central well and may be used directly in the respective procedure.
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 |
|---|---|---|---|---|
| MQK | Labware, Assisted Reproduction | Obstetrics/Gynecology | 884.6160 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17987 | Sperm filtration system | An assembly of devices incorporating filters that separate motile sperm from nonmotile sperm and seminal fluid/plasma for use in intrauterine insemination and other forms of assisted reproduction techniques. In some systems, the semen is filtered through a mechanical matrix filter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 25070002516204 | GS1 | 120 | In Commercial Distribution | ||
| Primary | 15070002516207 | GS1 | ||||
| Unit of Use | 05070002516200 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232980 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius