Procedure Pack
ZX1000 Mixing Bottle & Dosing Cup + Two Rovipharm 26489151 Oral Dosing Syringes
Oral Administration Set
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong.
- JWD. Technologies (Jiangmen) Co., Ltd. Guangdong
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.
How Is PXA Classified?
Oral Administration Set is FDA product code PXA, Class 1, 21 CFR 880.6430.
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.