Maquet Cardiovascular Us Sales, Llc

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Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide

Cardiohelp-I System || Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours). It is also intended to provide circulatory and/or pulmonary support during procedures not requiring cardiopulmonary bypass (for periods up to six hours).

510(k) numbers: 1<100278 (Bioline coated) Device Listing No. 0098004 BEQ-HMOD 30000 70064002-28 units 70064004-140 units

Cardiovascular Devices

2

No

Nationwide distribution: AL, CA, DE, DC, FL, GA, HI, IL, IN, LA, MI, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, and TX.

MAQUET QUADROX iD PEDIATRIC -OXYGENATOR: || BEQ-HMOD 3000; Made In Germany || The diffusion membrane oxygenator Quadrox iD pediatric is intended for use in an extracorporeal perfusion system. The oxygenator is designed for a blood flow rate of 0.2 -2.8 I/min and is intended for the treatment of pediatric patients. Within the specified flow rate range, the device oxygenates the blood, removes carbon dioxide and regulates the blood temperature.The utilization period for this device is restricted to six hours.

k100278 Lot number 70100610

Cardiovascular Devices

2

No

Distributed in DC, MA, & MI.

Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 || For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.

Order Number Model Number and Description Lot number 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 15674-05 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 15929-05 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 16115-06 70105.0647 BO-TOP 15200 OR Pack - HMO and RF 16346-06 70105.0967 BO-T 1260 Adult Cardioplegia Pack 15760-07 70105.0975 BO-TOP 26300 Custom Pack 15796-13 70105.1736 BEQ-TOP 4903 Open Heart Pack 15921-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16073-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16153-07 70105.1736 BEQ-TOP 4903 Open Heart Pack 16321-07 70105.1861 BO-TOP 14601 Open Heart Tubing Pack 15880-02 70105.2463 BO-T 25102 Custom Pack 15755-07 70105.2463 BO-T 25102 Custom Pack 15889-07 70105.2463 BO-T 25102 Custom Pack 16046-07 70105.2463 BO-T 25102 Custom Pack 16155-07 70105.2463 BO-T 25102 Custom Pack 16267-07 70105.2650 BO-TOP 23102 Scott &White; OR CPB Pack 15818-10 70105.2659 BO-TOP 4903 Adult Open Heart Pack 15780-03 70105.2659 BO-TOP 4903 Adult Open Heart Pack 16047-03 70105.3832 BO-TOP 32400 Adult CPB Pack 15814-06 70105.3832 BO-TOP 32400 Adult CPB Pack 16063-06 70105.3832 BO-TOP 32400 Adult CPB Pack 16449-06 70105.5015 BO-TOP 36500 Cardiac Surgery 15658-13 70105.5015 BO-TOP 36500 Cardiac Surgery 15772-13 70105.5015 BO-TOP 36500 Cardiac Surgery 15883-16 70105.5015 BO-TOP 36500 Cardiac Surgery 16078-16 70105.5015 BO-TOP 36500 Cardiac Surgery 16250-16 70105.5015 BO-TOP 36500 Cardiac Surgery 16410-17 70105.6041 BEQ-T 4906 Pediatric CPB Pack w/o VKMO 15819-02 70105.6238 BO-TOP 38800 Open Heart Pack 15635-05 70105.6238 BO-TOP 38800 Open Heart Pack 16013-05 70105.6867 BO-TOP 4112 1/4x3/16 Neonatal Pack 16039-09 70105.6867 BO-TOP 4112 1/4x3/16 Neonatal Pack 16238-10 70105.6869 BO-TOP 4113 Pediatric 1/4x3/8 15574-03 70106.2237 T 24260 St Louis Children¿s Cardioplegia 15659-05 70106.2237 T 24260 St Louis Children¿s Cardioplegia 15967-05 70106.2707 BEQ-TOP 40000 Open Heart Pack 15892-05 70106.2707 BEQ-TOP 40000 Open Heart Pack 16122-07 70106.2707 BEQ-TOP 40000 Open Heart Pack 16224-07 70106.3071 BEQ-TOP 30901 Custom CPB Pack 15783-05 70106.3071 BEQ-TOP 30901 Custom CPB Pack 15923-05 70106.3071 BEQ-TOP 30901 Custom CPB Pack 15998-05 70106.3071 BEQ-TOP 30901 Custom CPB Pack 16239-05 70106.3071 BEQ-TOP 30901 Custom CPB Pack 16387-05 70106.3364 BO-T 41760 Robert Packer Plegiox Set 15845-03 70106.3364 BO-T 41760 Robert Packer Plegiox Set 15976-03 70106.3364 BO-T 41760 Robert Packer Plegiox Set 16120-03 70106.3623 BO-T 31261 Plegiox Pack 15800-04 70106.3623 BO-T 31261 Plegiox Pack 15924-04 70106.3623 BO-T 31261 Plegiox Pack 16112-04 70106.3623 BO-T 31261 Plegiox Pack 16145-04 70106.3623 BO-T 31261 Plegiox Pack 16184-04 70106.4327 BO-TOP 48400 OR Pack 16169-01 70106.4327 BO-TOP 48400 OR Pack 16310-01 70106.5315 BEQ-T 16403 Liver TX 16114-06 70106.6206 BEQ-TOP 38307 Adult Pack 15931-03 70106.6398 BEQ-TOP 48000 Open Heart WITH Oxygenator 15932-02 70106.6400 BEQ-TOP 48001 Open Heart WITH OXY 15933-02 70106.6461 BEQ-TOP 38310 Small Adult Pack 15934-02 70106.6664 BEQ-T 4903 Open Heart Pack with NO VKMO 16040-01 70106.6712 BO-T 14601 Open Heart WITHOUT VKMO 16067-01 70106.6713 BEQ-T 40000 Open Heart WITHOUT VKMO 16056-01 70106.6738 BO-T 26300 Transitional Cardiac Surgery Pk 16146-01 70106.6914 BEQ-T 4961 Cardioplegia Pack 4:1 16240-01

Cardiovascular Devices

2

No

Worldwide Distribution - USA (nationwide) and the countries of Brazil, Germany and Turkey

MAQUET PLEGIOX Cardioplegia Heat Exchanger || The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours.

Part number 6481779

Anesthesiology Devices

2

No

Worldwide Distribution US, Canada and Japan.

Compressor Mini || To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.