Vacuum Powered Body Fluid Collection Kit
Which Manufacturers in China Make This?
The one Chinese manufacturer registered for this device type is based in Guangdong.
- Shenzhen BI-Rich Medical Devices Co., Ltd. Guangdong, contract manufacturer
What Is It?
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
How Is OJR Classified?
Vacuum Powered Body Fluid Collection Kit is FDA product code OJR, Class 2, 21 CFR 878.4780.
What Does It Take to Sell It in the United States?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
What Do the Recalls Say?
The FDA has recorded 1 recall under this product code since 2014. None was by a company in China. The root cause the FDA records most often is Component design/selection (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.