FDA-Device2015-05-06Class II
9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.
Medical Components, Inc dba MedComp
Hazard
The dual port with catheters was not covered under FDA clearance.
Sold states
Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.
Affected count
325
Manufactured in
1499 Delp Dr, Harleysville, PA, United States
Products
9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1527-2015Don't want to check this manually?
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