Enteral Administration Kit (Adult & Pediatric)
Which Manufacturers in China Make This?
7 manufacturers in China hold an FDA registration for this device type, concentrated in Zhejiang, Jiangsu and Henan, and 1 other province. 2 of them are contract manufacturers, able to build to a buyer’s own specification.
- Amsino Medical (Kunshan) Co., Ltd. Jiangsu, contract manufacturer
- Boen Healthcare Co., Ltd. Jiangsu
- Evereast Medical Products Group Co., Ltd. Henan, contract manufacturer
- Huzhou Junda Industry Co., Ltd. Zhejiang, contract manufacturer
- Ningbo Hanyue Medical Technology Co., Ltd. Zhejiang, contract manufacturer
- Ningbo Luke Medical Devices Co., Ltd. Zhejiang, contract manufacturer
- Shandong Zhushi Pharmaceutical Group Co., Ltd. Shandong, 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 PRM?
Enteral Administration Kit (Adult & Pediatric) is FDA product code PRM, Class 2, 21 CFR 876.5980.
How Does It Reach the US Market?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.