OBB

Kit, Conception-Assist, Home Use

产品代码

OBB

器械名称

Kit, Conception-Assist, Home Use

管理类别

第 2 类（Class II）

21 CFR 条款

21 CFR 884.5250

FDA 专业组

Obstetrics/Gynecology

上市路径

需提交 510(k) 上市前通告

该代码近三年的 510(k)

4 件

FDA 分类定义

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.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。