Profile: Welch Allyn GmbH & Co. KG is a manufacturer of medical devices, products and solutions used by caregivers in doctors' offices, hospitals & emergency response settings. Pocket Junior otoscope is a light and compact otoscope that provides brighter light, a wider view & has handle artwork customization. It features lightweight & compact size, fiber optic light transmission, wide angle magnifying lens, insufflation port for pneumatic otoscopy and standard AA batteries with interchangeable heads for otoscope & ophthalmoscope. The Elite distributor allows connecting up to five headsets to one stethoscope for group listening. This set-up is ideal for teaching, allowing all five individuals to hear a patient's body sounds at the same time. Each person can then make his own diagnosis based on the same sounds. It is a simple way to train students and residents in auscultation & physical diagnosis. Both the double- and triple-head Harvey DLX stethoscopes are specifically designed to accentuate important sounds & enable hearing cardiac, pulmonary, and vascular sounds without relying on variable pressure techniques. The Harvey DLX is equipped with dual-bore tubing that creates two uninterrupted sound channels and works with the optimally weighted brass chestpieces to transmit a full range of physical sounds.

The company has revenues of USD 10-25 Million and is ISO 9000, ISO 9001, ISO 9002, CE certified.

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• AC-Powered Medical Examination Device (FDA Code: KZF / 880.6320) An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

• AC-Powered Operating Headlamp (FDA Code: HPQ / 886.4335) An operating headlamp is an AC-powered or battery-powered device intended to be worn on the user's head to provide a light source to aid visualization during surgical, diagnostic, or therapeutic procedures.

• AC-Powered Ophthalmoscope (FDA Code: HLI / 886.1570) An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.

• AC-Powered Perimeter (FDA Code: HOO / 886.1605) A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.

• Ambulatory Electrocardiograph (ECG) Analysis Systems (FDA Code: MLO / 870.2800) A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

• Anoscope and Accessories (FDA Code: FER / 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.

• Apnea Monitors (FDA Code: FLS / 868.2377) An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.

• 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.

• Audiometers (FDA Code: EWO / 874.1050) An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.

• Auditory Impedance Tester (FDA Code: ETY / 874.1090) An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.

• Automatic External Defibrillator (FDA Code: MKJ / 870.5310) An automated external defibrillator (AED) is a low-energy device with a rhythm recognition detection system that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart. An AED analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

• Automatic Indirect Blood Pressure Monitor

• Battery-Powered Medical Examination Light (FDA Code: KYT / 880.6350) A battery-powered medical examination light is a battery-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

• Battery-Powered Ophthalmoscope (FDA Code: HLJ / 886.1570)

• Battery-Powered Retinoscope (FDA Code: HKM / 886.1780) A retinoscope is an AC-powered or battery-powered device intended to measure the refraction of the eye by illuminating the retina and noting the direction of movement of the light on the retinal surface and of the refraction by the eye of the emergent rays.

• Battery-Powered Transilluminator (FDA Code: HJN / 886.1945) A transilluminator is an AC-powered or battery-powered device that is a light source intended to transmit light through tissues to aid examination of patients.

• Blood Level Detector (FDA Code: FJC / 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.

• Blood Pressure Cuff Barriers

• Blood Pressure Cuff With Inflation Systems

• Blood pressure Cuffs (FDA Code: DXQ / 870.1120) A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

• Blood Pressure Cuffs and Neoprene Bladders (1-Tube)

• Blood Pressure Cuffs and Neoprene Bladders (2-Tube)

• Blood Pressure Cuffs With Bayonet Connectors

• Blood Pressure Cuffs With Locking-Type Connectors

• Blood Pressure Cuffs With Luer Lock Connectors

• Blood Pressure Cuffs With Screw-Type Connectors

• 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.

• Colposcope and Accessories (FDA Code: HEX / 884.1630) A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.

• 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.

• Cryosurgical Unit (FDA Code: GEH / 878.4350)

• Diagnostic Spirometer (FDA Code: BZG / 868.1840) A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.

• Disposable Covers for Blood Pressure Cuffs

• Ecg Analysis System (FDA Code: LOS)

• 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.

• Electronic Stethoscopes (FDA Code: DQD / 870.1875) A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

• Electronic-Amplified Stethoscope

• Endoscope Accessories (FDA Code: KOG)

• ENT Mirror (FDA Code: KAI / 874.4420)

• Fiberoptic Surgical Light (FDA Code: FST / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Flexible/Rigid Nasopharyngoscope (FDA Code: EOB / 874.4760) A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.

• 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.

• Gynecologic Electrocautery and Accessories (FDA Code: HGI / 884.4120) A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.

• Gynecological Biopsy Forceps (FDA Code: HFB / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Indirect Blood Pressure Monitor

• Infant Disposable Blood Pressure Cuffs

• Inflation Bulb For Endoscope (FDA Code: FCY / 876.1500)

• Infusion Stand (FDA Code: FOX / 880.6990) The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.

• Intravenous Blood Flowmeter (FDA Code: DPW / 870.2100) A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.

• Low Energy DC-Defibrillator (FDA Code: LDD / 870.5300) A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.

• Low Power Binocular Loupe (FDA Code: HJH / 886.5120) A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.