Enteral Administration Kit (adult & Pediatric)
Gastroenterology, Urology · 21 CFR 876.5980
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.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
14 firms currently registered for this product code
Ningbo Hanyue Medical Technology Co.,ltd
CIXI CITY Zhejiang, CN
Cardinal Health (kenmex Medical Specialties)
TIJUANA Baja California, MX
Metier Medical Sp. Z O.o.
ZRODLA Dolnoslaskie, PL
Hospi Corporation
San Mateo, CA, US
Create Biotech Co., Ltd.
Taoyuan City, TW
Huzhou Junda Industry Co., Ltd.
Anji Zhejiang, CN
Cardinal Health 200, Llc
Waukegan, IL, US
Cardinal Health
Hazelwood, MO, US
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Evereast Medical Products Group Co., Ltd
Changyuan City Henan, CN
Shandong Zhushi Pharmaceutical Group Co., Ltd
Heze Shandong, CN
Amsino Medical (kunshan) Co., Ltd.
KUNSHAN CITY Jiangsu, CN
Ningbo Luke Medical Devices Co., Ltd.
Yuyao Zhejiang, CN
Biorad Medisys Pvt. Ltd.
Pune Maharashtra, IN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.