CentriMag
TM
Circulatory Support System Operation Manual (US)
Page 7 of 126
© 2019 Abbott – Document No PL-0047, Rev 11 (December 2019)
Indications for Use Chart
Product Name and
Market Application
Number
Refer to Label Part
No.
Required US
Caution
Statement(s)
Indications for Use
provide temporary
circulatory support
for up to 30 days for
patients in
cardiogenic shock
due to acute right
ventricular failure.
The effectiveness of
this device for this
use has not been
demonstrated.
provide temporary
circulatory support
for up to 30 days for
patients in
cardiogenic shock
due to acute right
ventricular failure.
The effectiveness of
this device for this
use has not been
demonstrated.
CentriMag
Extracorporeal
Blood Pumping
System
K020271
K051209
K053630
K081221
K083340
K090004
K102129
K131179
PL-0070, CentriMag
Blood Pump IFU
Federal (U.S.A.) law
restricts this device
to sale, distribution
and use by or on the
order of a physician.
The CentriMag
Blood Pump is
indicated for use
with the 2
nd
Generation
CentriMag Primary
Console to pump
blood through the
extracorporeal
bypass circuit for
extracorporeal
circulatory support
for periods ap-
propriate to
cardiopulmonary
bypass (CPB) for up
to six hours. It is
also indicated for
use in
extracorporeal
support systems (for
periods up to six
hours) not requiring
complete CPB (e.g.
valvuloplasty,
circulatory support
during mitral valve
reoperation, surgery
of the vena cava or
aorta, liver
transplants etc.)
This device is not
designed, sold, or
intended for use
except as indicated.
PediMag Blood
PL-0112, PediMag
Federal (U.S.A.) law
The PediMag Blood