What is FDA product code OBB?

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.

Obstetrics & Gynecology › TherapeuticKit, Conception-Assist, Home Use

Conception Kit

Name: Conception Kit
Brand: 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.

Registry build 21.09.26

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OBB
Manufacturer	City	Province	Registered as	Device types
Immetech Industrial Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	2

Record

Regulatory record for Conception Kit
Listed by	Conceivex, Inc., United States
FDA product code	OBB
Device type	Kit, Conception-Assist, Home Use
Device class	Class 2
Regulation	21 CFR 884.5250
Record published	2018-09-01
Record revised	2019-02-21 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date, serial number
Storage	Handling environment temperature 35 to 86 °F

Catalogue Numbers

Catalogue numbers for Conception Kit
Catalogue number	Size	Status
CX-0002-ML EN/ES	Wide 9 inches	In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
The Stork OTC	Stork IB2C, Inc., THE	7

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K080752	2008-05-14
K063227	2007-03-14

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.