Profile: Instrumentarium Corp. manufactures anesthesia machines, patient monitoring devices, drug delivery systems, medical & dental X-ray equipment, and infant care systems.

The company has revenues of USD 100-500 Million, has ~3600 employees and is ISO 9000, CE certified.

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• A.V. Fistula Needle

• A.V.Fistula Needle Set

• AC-Powered Portable Ward Use Suction Apparatus (FDA Code: JCX / 878.4780) A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

• Acute Care Physiological Monitor

• Adjustable Hospital AC-Powered Beds (FDA Code: FNL / 880.5100) An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

• Anesthesia Gas-Machine (FDA Code: BSZ / 868.5160) A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.

• Anesthesia Unit Gas Scavenger

• Anesthesia Unit Ventilator

• Anesthetic Gas Analyzer

• Arrhythmia Detector and Alarm (FDA Code: DSI / 870.1025) The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

• Arterial Venous Fistula Needle

• Automatic Delivery Peritoneal System (FDA Code: FKX / 876.5630) (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.

• Batteries & Battery Assemblies for Pulse Oximeters

• Blood Pressure Transducer

• Blood Volume Measuring Device (FDA Code: JWO / 864.5950) A blood volume measuring device is a manual, semiautomated, or automated system that is used to calculate the red cell mass, plasma volume, and total blood volume.

• Cannula Fistula Needle

• Carbon-Dioxide Absorber (FDA Code: BSF / 868.5310) A carbon dioxide absorber is a device that is intended for medical purposes and that is used in a breathing circuit as a container for carbon dioxide absorbent. It may include a canister and water drain.

• Cardiac Monitor (Cardiotachometer and Rate Alarm) (FDA Code: DRT / 870.2300) A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

• Cardiopulmonary Bypass Oxygenator (FDA Code: DTZ / 870.4350) A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.

• Charcoal Water Purification Filter

• Continuous Airway Pressure Monitor

• Continuous Monitor Oxygen Gas Analyzer

• Continuous Ventilator (FDA Code: CBK / 868.5895) A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

• Dialysate Tube (FDA Code: FID / 876.5820) A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

• Dialysis Standard-Conductivity Solution-Test (FDA Code: FKH / 876.5820)

• Dialyzer Holder Set (FDA Code: FKI / 876.5820)

• Digital Pulse Oximeter

• Disposbale Pulse Oximeter Sensors

• Dual Lumen Fistula Needle

• ECG Monitor

• ECG Monitoring Electrodes

• ECG Monitors Service

• EEG Monitor

• Electric Beds

• Electrocardiograph (FDA Code: DPS / 870.2340) An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

• Electroencephalograph Digital EEG Monitor

• Event ECG Monitors

• Fetal Pulse Oximeter (FDA Code: MMA)

• Fingertip Pulse Oximeter

• Fistula Needle (FDA Code: FIE / 876.5540) A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

• Gaseous Phase Carbon-Dioxide Gas Analyzer (FDA Code: CCK / 868.1400) A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

• Gaseous Phase Enflurane Gas Analyzer (FDA Code: CBQ / 868.1500) An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.

• Gaseous Phase Nitrous-Oxide Gas Analyzer (FDA Code: CBR / 868.1700) A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.

• Gastrointestinal Tube and Accessories (FDA Code: KNT / 876.5980) A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).

• General & Plastic Surgery Pediatric Catheter (FDA Code: GBN / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Guarded Fistula Needles

• Handheld Capnograph with Pulse Oximeter

• Handheld Pulse Oximeter

• Heart-Lung Bypass Unit

• Heartline ECG Monitoring System