Ultra 8 IAB

Lot Numbers: KF0087756 MF0053016 MF0053017 MF0053018 MF0053019 MF0073778 MF0074136 MF0074137 MF5114292 MF7076257 MF7118004 MF7128505 MF8103263 MF8124064 MF8124178 MF8124307 MF8124408 MF9014573 MF9025207 MF9025208 MF9025213 MF9025226 MF9025227 MF9035382 MF9035448 MF9046246 MF9056839 MF9056840 MF9057065 MF9057066 MF9067735 MF9067736 MF9077955 MF9077968 MF9077969 MF9078203 MF9078343 MF9088501 MF9099356 MF9099357 MF9099358 MF9099359 MF9110054 MS9056710 MS9057152 MS9057153 MS9109664 MS9110295 MS9110368

Cardiovascular Devices

2

No

Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Colombia, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.

Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 30cc. || Model: IAB-05830-U

Lot Numbers: KF0087855 KF0087856 KF0098040 KF0108374 MF0011189 MF0021654 MF0032271 MF0042406 MF0042501 MF0042786 MF0053023 MF0063353 MF0073903 MF0074071 MF7065606 MF7086741 MF7118151 MF7128507 MF8103280 MF8103571 MF8113919 MF8113951 MF8124345 MF9014575 MF9014817 MF9024965 MF9024993 MF9025112 MF9025209 MF9035509 MF9035685 MF9035955 MF9046057 MF9046247 MF9046501 MF9056746 MF9057069 MF9057070 MF9067275 MF9067738 MF9067740 MF9077954 MF9078048 MF9078052 MF9078348 MF9078349 MF9088685 MF9100025 MS0053114 MS9056684 MS9056857 MS9057154 MS9110263 MS9110269

Cardiovascular Devices

2

No

Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Colombia, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.

Arrow Ultra 8 IAB (Intra-Aortic Balloon) Catheter, 8 Fr, 40cc. || Model: IAB-05840-U

Lot Numbers: KF0118523 MF8092597 MF8103402 MF8114055 MF9014548 MF9046091 MF9056823 MF9057130 MF9078053 MF9088776 MF9099410 MF9109907

Cardiovascular Devices

2

No

Worldwide Distribution -- USA, Canada, Australia, Belgium, Czechoslovakia, Germany, Russia, Spain, Finland, France, Great Britain, Hungary, Italy, Netherlands, Poland, Saudi Arabia, Switzerland, Brazil, Australia, Chile, Colombia, Ecuador, India, Indonesia, Japan, Korea, Malaysia, Mexico, New Zealand, Panama, Peru, Philippines, Taiwan, Thailand, and Venezuela.

Percutaneous Insertion Tray For Use with: Arrow Ultra 8 IAB (Intra Aortic Balloon) Catheters || Model: IAK-05845

Batch: 18F14A0031 18F14A0032 18F14A0033 18F14D0066 18F14E0018 18F14E0072 18F14F0067 18F14F0079 18F14G0045 18F14G0046 18F14G0081 18F14H0037 18F14J0023 18F14L0014 18F14M0033 18F15A0010 18F15B0015 18F15C0004 18F15C0023 18F15D0025 18F15D0052 18F15E0020 18F15F0002 18F15F0039 18F15G0005 18F15G0015 18F15H0006 18F15H0037 18F15H0051 18F15J0026 18F15L0007 18S14G0046

Cardiovascular Devices

2

No

Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).

FiberOptix Ultra 8 IAB: 8Fr 30cc || The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Batch: 18F14A0031 18F14A0032 18F14A0033 18F14D0066 18F14E0018 18F14E0072 18F14F0067 18F14F0079 18F14G0045 18F14G0046 18F14G0081 18F14H0037 18F14J0023 18F14L0014 18F14M0033 18F15A0010 18F15B0015 18F15C0004 18F15C0023 18F15D0025 18F15D0052 18F15E0020 18F15F0002 18F15F0039 18F15G0005 18F15G0015 18F15H0006 18F15H0037 18F15H0051 18F15J0026 18F15L0007 18S14G0046

Cardiovascular Devices

2

No

Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).

Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U || The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.