Subcutaneous Injection Supply Kit
The parenteral administration kit is composed to support the home application of a subcutaneous injection of fluids for medical purposes.
Parenteral Administration Kit
Who Makes This Device Type in China?
5 manufacturers in China hold an FDA registration for this device type, concentrated in Guangdong, Hubei and Hunan, and 2 other provinces.
- Jiangsu Guangda Medical Material Group Co., Ltd. Jiangsu, contract manufacturer
- Winner Medical (Hunan) Co., Ltd. Hunan, contract manufacturer
- Winner Medical Co., Ltd. Guangdong
- Winner Medical (Chongyang) Co., Ltd. Hubei, contract manufacturer
- Zhejiang Kindly Medical Devices Co., Ltd. Zhejiang, 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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080216.htm . This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
How Is POR Classified?
Parenteral Administration Kit is FDA product code POR, Class 2, 21 CFR 880.5440.
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.
Name
Record
Subcutaneous Injection Supply Kit 2
The parenteral administration kit is composed to support the home application of a subcutaneous injection of fluids for medical purposes.