Conception Kit
Lot number, Expiration Date, Individual Kit Number, Temperature Range and the statement: The Conception Kit should be kept away from direct sunlight, moisture and heat.
Kit, Conception-Assist, Home Use
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Guangdong. All of them are contract manufacturers, able to build to a buyer’s own specification.
- Immetech Industrial Co., Ltd. Guangdong, contract manufacturer
What Is It?
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.
What Is FDA Product Code OBB?
Kit, Conception-Assist, Home Use is FDA product code OBB, Class 2, 21 CFR 884.5250.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.
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