FDA UDI
In Commercial Distribution
🇺🇸 United States
Béa Fertility
DI: 05065015660064
·
Model: BTK-US-01
·
STEPONE FERTILITY LTD
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Béa Fertility
- Primary DI
- 05065015660064
- Version / Model
- BTK-US-01
- Company Name
- STEPONE FERTILITY LTD
- Labeler DUNS
- 225808762
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-24
- Public Version
- 1
- Public Version Date
- 2025-08-01
- Public Version Status
- New
- Public Device Record Key
- 1491dd5d-6013-4155-9aa7-ab466502c9a9
Device Description
Béa Treatment Kit
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| HDR | Cap, Cervical | Obstetrics/Gynecology | 884.5250 | 2 |
| FMH | Container, Specimen, Sterile | Pathology | 864.3250 | 1 |
| OBB | Kit, Conception-Assist, Home Use | Obstetrics/Gynecology | 884.5250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61449 | Conceptive cervical cap, single-use | A flexible device designed to promote conception, either by serving as a container to introduce semen into the cervix, or by acting as a cervical cup that allows sperm to be held in place for easier access to the cervical os. It is a plastic device which may have a condom-like sheath for semen collection, and may be supplied with a dedicated applicator. The device is used to aid conception in couples who have experienced difficulties due to low sperm counts, reduced sperm motility or a hostile vaginal environment; and also for self or assisted insemination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05065015660064 | GS1 |