Transonic Systems Inc

Lots B151130E2 and B161115E0

Gastroenterology-Urology Devices

2

No

Worldwide Distribution - USA (nationwide) Distribution and to the states of : NJ, NY, OH, PA, and TX., and to the countries of : Canada, South Korea, Thailand, Australia and Taiwan.

Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 || The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.

Serial Numbers: HQD6FMV2469, HQD6FMV2470

Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- || Product Usage: || to measure flow intra-operatively.

Serial Numbers: HQD4FMC3504, HQD4FMC3505, HQD4FMC3506, HQD4FMC3507, HQD4FMC3508, HQD4FMC3509, HQD4FMC3510, HQD4FMC3511, HQD4FMC3512, HQD4FMC3513, HQD4FMC3514, HQD4FMC3515, HQD4FMC3516, HQD4FMC3517, HQD4FMC3518, HQD4FMC3519, HQD4FMC3520

Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: || to measure flow intra-operatively.

Serial Numbers: HQD3FMC3763, HQD3FMC3764, HQD3FMC3765, HQD3FMC3766, HQD3FMC3767, HQD3FMC3768, HQD3FMC3769, HQD3FMC3770, HQD3FMC3771, HQD3FMC3772, HQD3FMC3773, HQD3FMC3774, HQD3FMC3775, HQD3FMC3776, HQD3FMC3777, HQD3FMC3778, HQD3FMC3779, HQD3FMC3780, HQD3FMC3781, HQD3FMC3782, HQD3FMC3783, HQD3FMC3784, HQD3FMC3785, HQD3FMC3786, HQD3FMC3787, HQD3FMC3788, HQD3FMC3789, HQD3FMC3790, HQD3FMC3791, HQD3FMC3792, HQD3FMC3793, HQD3FMC3794, HQD3FMC3795, HQD3FMC3796, HQD3FMC3797, HQD3FMC3798, HQD3FMC3799, HQD3FMC3800, HQD3FMC3801, HQD3FMC3802, HQD3FMC3803, HQD3FMC3804, HQD3FMC3805, HQD3FMC3806, HQD3FMC3807, HQD3FMC3814, HQD3FMC3815

Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- || Product Usage: || to measure flow intra-operatively.

Serial Numbers: HQD2FMC2797, HQD2FMC2873, HQD2FMC2874, HQD2FMC2875, HQD2FMC2876, HQD2FMC2877, HQD2FMC2878, HQD2FMC2879, HQD2FMC2880, HQD2FMC2881, HQD2FMC2882, HQD2FMC2883, HQD2FMC2884, HQD2FMC2885, HQD2FMC2886, HQD2FMC2888, HQD2FMC2889, HQD2FMC2890, HQD2FMC2908

Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide and the countries of: Canada, Japan, Russia and The Netherlands.

Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- || Product Usage: || to measure flow intra-operatively.