Sorin Group USA, Inc.

Click Here To EMAIL INQUIRY
Contact: Don Todd - VP Sales
Web: http://www.soringroup-usa.com
E-Mail:
Address: 14401 W. 65th Way, Arvada, Colorado 80004-3599, USA
Phone: +1-(303)-425-5508, 800-221-7943 | Fax: +1-(303)-467-6584 | Map/Directions >>

Profile: Sorin Group USA, Inc. designs and manufactures cardiac perfusion & blood management systems. Our D100 oxygenator is designed for neonatal procedures. It is designed to reduce allogenic blood product usage and can have a positive effect on patient outcomes. The flow rates are under 700 cc/minute. Our D130 arterial filter is small in size. The combination of an oxygenator and filter allows optimal reduction of the priming volume of extracorporeal circuit.

The company was founded in 1999, has revenues of USD 100-500 Million, has ~680 employees.

FDA Registration Number: 1718850

41 Products/Services (Click for related suppliers)

• Arterial Filters

• Arterial Line Cardiopulmonary Bypass Blood Filter (FDA Code: DTM / 870.4260)

A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.

• Automated Hematocrit Instrument (FDA Code: GKF / 864.5600)

An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

• Autotransfusion Apparatus (FDA Code: CAC / 868.5830)

An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.

• Blood Cardiopelegia Systems

• Cardiopulmonary Bypass Accessories (FDA Code: KRI / 870.4200)

Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator mounting bracket or system-priming equipment.

• Cardiopulmonary Bypass Adaptor (FDA Code: DTL / 870.4290)

A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

• Cardiopulmonary Bypass Blood Reservoir (FDA Code: DTN / 870.4400)

A cardiopulmonary bypass blood reservoir is a device used in conjunction with short-term extracorporeal circulation devices to hold a reserve supply of blood in the bypass circulation.

• Cardiopulmonary Bypass Heat Exchanger (FDA Code: DTR / 870.4240)

A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

• Cardiopulmonary Bypass Pump Tube (FDA Code: DWE / 870.4390)

A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.

• Cardiopulmonary Bypass Vascular Catheter (FDA Code: DWF / 870.4210)

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

• Cardiopulmonary Systems, Oxygenator

• Cardiopulmonary Systems, Perfusion System

• Cardiotomy Reservoir Brackets

• Cell-Saver Machines

• Centrifugal Pump System

• Continuous Electronic Thermometer (FDA Code: FLL / 880.2910)

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400)

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Embolectomy Catheters (FDA Code: DXE / 870.5150)

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

• Endoscope Accessories (FDA Code: KOG)

• Endoscopic Vessel Harvesting System

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Heart Lung Machine

• Implantable Staple (FDA Code: GDW / 878.4750)

An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.

• In-Line Retrograde Flow CPB Check Valve (FDA Code: MJJ / 870.4400)

• Lamina Perfusion Tubing

• Neonatal Arterial Filters

• Non-Sterile Tubing Segments

• Operating Room Equipment, Cell Saver Machines

• Oxygenators

• Pediatric Oxygenators &Reservoirs

• Refrigerated Centrifuges (FDA Code: JQC / 862.2050)

General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• Rigid Endoscopes (FDA Code: GCM / 876.1500)

• Rigid Tip Suckers

• Sterile Tubing Segments

• Surgical Vessel Dilator (FDA Code: DWP / 870.4475)

A surgical vessel dilator is a device used to enlarge or calibrate a vessel.

• Tubing Clamps

• Uncompensated Thorpe Tube (FDA Code: BYM / 868.2320)

An uncompensated thorpe tube flowmeter is a device intended for medical purposes that is used to indicate and control gas flow rate accurately. The device includes a vertically mounted tube and is calibrated when the outlet of the flowmeter is open to the atmosphere.

• Vanguard Cardioplegia Delivery Systems

• Versaplegia Delivery Systems