Capiox® iCP Centrifugal Pump - 3CX*CP8
Device Description
A device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: KFM
Device Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.4360
Third Party Flag: N
Medical Specialty: CV
Device IdentifiersDevice Id: 50699753450962
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00699753450967
Package Quantity: 8
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: 8 Piece Case
Device Id: 00699753450967
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A