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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• Low-Vision Spectacle Microscope (FDA Code: HKC / 886.5540) A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles.

• Manual Stethoscope (FDA Code: LDE / 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.

• Mercury Sphygmomanometer

• Metal Vaginal Speculum (FDA Code: HDF / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• Microscope Micrometer (FDA Code: KEH / 864.3600) Microscopes and accessories are optical instruments used to enlarge images of specimens, preparations, and cultures for medical purposes. Variations of microscopes and accessories (through a change in the light source) used for medical purposes include the following:

• MRI Safe Blood Pressure Cuff

• Neonatal Apnea Monitor (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.

• Neonatal Disposable Blood Pressure Cuffs

• Non Dental Irrigating Syringe (FDA Code: KYZ / 880.6960) An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.

• Non Invasive External Transcutaneous Cardiac Pacemaker (FDA Code: DRO / 870.5550) An external transcutaneous cardiac pacemaker (noninvasive) is a device used to supply a periodic electrical pulse intended to pace the heart. The pulse from the device is usually applied to the surface of the chest through electrodes such as defibrillator paddles.

• Non Rigid Laryngoscope (FDA Code: CAL / 868.5530) A flexible laryngoscope is a fiberoptic device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

• Non-Electrical Rigid Sigmoidoscope (FDA Code: KDM / 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.

• Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN / 870.1130) A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

• Non-Metal Vaginal Speculum (FDA Code: HIB / 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:

• Non-Powered Rectal Probe (FDA Code: EXX / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Ophthalmic Eye Shield (FDA Code: HOY / 886.4750) An ophthalmic eye shield is a device that consists of a plastic or aluminum eye covering intended to protect the eye or retain dressing materials in place.

• Ophthalmic Refractometer (FDA Code: HKO / 886.1760) An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.

• Oscillometer (FDA Code: DRZ / 870.2675) An oscillometer is a device used to measure physiological oscillations of any kind, e.g., changes in the volume of arteries.

• Otoscopes (FDA Code: ERA / 874.4770) An otoscope is a device intended to allow inspection of the external ear canal and tympanic membrane under magnification. The device provides illumination of the ear canal for observation by using an AC- or battery-powered light source and an optical magnifying system.

• Oximeters (FDA Code: DQA / 870.2700) An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

• Paper Chart Recorder (FDA Code: DSF / 870.2810) A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer.

• Paracervical Anesthesia Set (FDA Code: HEE / 884.5100) An obstetric anesthesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended for use with an anesthetic drug. This device is used to administer regional blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during labor, delivery, or both.

• Patient Physiological Monitor (FDA Code: MHX / 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.

• Patient Physiological Monitor without Arrhythmia Detection (FDA Code: MWI / 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.

• Physiological Monitors Network and Communication System (FDA Code: MSX / 870.2300)

• Pneumatic Tourniquet (FDA Code: KCY / 878.5910) A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery.

• Powered Surgery Indirect Blood Pressure Monitor

• Programmable Diagnostic Computer (FDA Code: DQK / 870.1425) A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

• Radiological Image Processing System (FDA Code: LLZ / 892.2050) A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

• Rigid Laryngoscope (FDA Code: CCW / 868.5540) A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

• Routine Fiberoptic Light Source (FDA Code: FCW / 876.1500)

• ST Segment Monitor with Alarm (FDA Code: MLD / 870.1025)

• Surgical Camera and Accessories (FDA Code: KQM / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures.

• Surgical Headband Light (FDA Code: FSR / 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.

• Surgical Television Camera with Audio (FDA Code: FWC / 878.4160)

• Unipolar Endoscopic Coagulator-cutter and Accessories (FDA Code: KNF / 884.4160) A unipolar endoscopic coagulator-cutter is a device designed to destroy tissue with high temperatures by directing a high frequency electrical current through the tissue between an energized probe and a grounding plate. It is used in female sterilization and in other operative procedures under endoscopic observation. This generic type of device may include the following accessories: an electrical generator, probes and electrical cables, and a patient grounding plate. This generic type of device does not include devices used to perform female sterilization under hysteroscopic observation.

• Wall Vacuum-Powered Operating Room Suction Apparatus (FDA Code: GCX / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Xenon Arc Endoscope Light Source (FDA Code: GCT / 876.1500)