FDA UDI
In Commercial Distribution
🇺🇸 United States
LensHooke Sperm Separation Device
DI: 14719874742239
·
Model: CA0 Package-25 sets-US-HT
·
BONRAYBIO CO., LTD.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- LensHooke Sperm Separation Device
- Primary DI
- 14719874742239
- Version / Model
- CA0 Package-25 sets-US-HT
- Catalog Number
- CA0
- Company Name
- BONRAYBIO CO., LTD.
- Labeler DUNS
- 658872369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2025-02-16
- Public Version
- 2
- Public Version Date
- 2025-04-21
- Public Version Status
- Update
- Public Device Record Key
- d731d3d5-4752-4ddb-9cb4-d69b65c752a6
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 14719874742239 | GS1 | ||||
| Unit of Use | 04719874742232 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K221810 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 36 – 86 Degrees Fahrenheit
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 38 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 59 – 100 Degrees Fahrenheit
- Type
- Handling Environment Humidity
- Temperature Range
- – 70 Percent (%) Relative Humidity