Umbilical Catheter Insertion Tray
Who Makes This Device Type in China?
One manufacturer in China holds an FDA registration for this device type, based in Hubei.
- Hubei Lanbin Medical Group Co., Ltd. Hubei, contract manufacturer
What Is This Device?
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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.
What Is FDA Product Code PXJ?
Umbilical Catheter Insertion Tray is FDA product code PXJ, Class 2, 21 CFR 880.5200.
How Does It Reach the US Market?
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.