Parenteral Administration Kit
General Hospital · 21 CFR 880.5440
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.
Recent MDR events
1 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
18 firms currently registered for this product code
Sol-millennium Medical, Inc.
Chicago, IL, US
Convertors De Mexico S. De R.l. De C.v
CD.JUAREZ Chihuahua, MX
Sterigenics Us Llc
Grand Prairie, TX, US
Zhejiang Kindly Medical Devices Co., Ltd
WENZHOU Zhejiang, CN
Winner Medical (hunan) Co., Ltd.
Changde Hunan, CN
Isomedix Operations Inc
El Paso, TX, US
Toc Logistics / Sol-millenium Canada, Inc.
Balzac Alberta, CA
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Winner Medical (chongyang) Co., Ltd.
Chongyang Hubei, CN
Isomedix Operations Inc
EL PASO, TX, US
Takeda Pharmaceuticals U.s.a., Inc.
Cambridge, MA, US
Cardinal Health 200, Llc
El Paso, TX, US
Winner Medical Co., Ltd.
SHENZHEN Guangdong, CN
Sterigenics U.s., Llc
Charlotte, NC, US
Toc Logistics / Sol-millenium Canada, Inc.
Maple Ontario, CA
B. Braun Melsungen Ag
MELSUNGEN Hesse, DE
Cardinal Health 200, Llc
Waukegan, IL, US
Jiangsu Guangda Medical Material Group Co., Ltd.
Haian Jiangsu, CN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.