Kit, Conception-Assist, Home Use
- US Product Code (FDA)
- OBBView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 884.5250View CFR Regulation →
- Medical specialty
- Obstetrics/Gynecology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
The kit is intended for assisted insemination in situations in which low sperm count , sperm immobility, or hostile vaginal environment have been diagnosed. The kit is used for semen collection and placement into the bowl of a cervical cap as an aid to conception. It is to be used at home following physician instruction. The Cap should not be left in place for more than 6 hours. The kit consists of: conception (cervical) caps; 3 polyurethane condoms; 24 ovulation predictors; 3 pregnancy test kits; 3 "sperm friendly" moisturizer samples (Pre Lubricant); 1 conception journal; 1 instruction manual; 2 conception wheels (1 in English and 1 in French); 1 medical provider envelope.
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Kit, Conception-Assist, Home Use is a medical device type in the Obstetrics/Gynecology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
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