(FDA Code:
MHD /
880.5725)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Classification. Class II (performance standards).
Thermo Fisher Scientific Inc
Ametek, Inc.
A Gamma Camera is a device used to image gamma radiation emitting radioisotopes, a technique known as scintigraphy. The applications of scintigraphy include early drug development and nuclear medical imaging to view and analyse images of the human body of the distribution of medically injected, inhaled, or ingested radionuclides emitting gamma rays. A gamma camera consists of one or more flat crystal planes or, detectors, optically coupled to an array of photomultiplier tubes, the assembly is known as a 'head', mounted on a gantry. The gantry is connected to a computer system that both controls the operation of the camera as well as acquisition and storage of acquired images. The system accumulates events, or counts, of gamma photons that are absorbed by the crystal in the camera. Usually a large flat crystal of sodium iodide with thallium doping in a light-sealed housing is used. The crystal scintillates in response to incident gamma radiation. When a gamma photon leaves the patient, who has been injected with a radioactive pharmaceutical, it knocks an electron loose from an iodine atom in the crystal, and a faint flash of light is produced when the dislocated electron again finds a minimal energy state. The initial phenomenon of the excited electron is similar to the photoelectric effect and particularly with gamma rays the Compton effect. After the flash of light is produced, it is detected. Photomultiplier tubes (PMTs) behind the crystal detect the fluorescent flashes events and a computer sums the counts.
Farber Medical Solutions, LLC,
Orbit Medical Technologies, Inc.,
Futrex, Inc.,
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Spectra Medical Devices, Inc.,
Dealmed Medical Supplies,
Associated Bag Co,
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Precision Medical Inc.,
S4J Manufacturing Services, Inc.,
Woodhead L.P.,
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TriE Medical, Inc.
Mercury Medical,
Allied Healthcare Products Inc,
Mada, Inc.,
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Andersen Products, Inc.,
Airgas-North Central, Inc.
Andersen Products, Inc.,
Kordon Tip Ltd.
Squire-Cogswell/Aeros Instruments Inc.
Halyard Health, Inc.,
Medtronic, Inc.,
American HomePatient,
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Cook Group Incorporated,
Covidien,
Medovations, Inc.,
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Covidien,
Medtronic, Inc.,
American HomePatient,
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R. B. Annis Instruments, Inc.,
Walker LDJ Scientific, Inc.,
Lake Shore Cryotronics, Inc.
The gauze balls are produced from bleached cotton fibers. It is an inseparable part of medical procedures in surgery, traumatology, and other medical applications.
Bosgen Inc.,
Shreeji Surgical,
China Surgical Dressings Ctr. Co. Ltd.,
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Jant Pharmacal Corp.,
Shreeji Surgical,
Laboratorios Indas, S.A.U.,
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Miltex, Inc.,
Himalaya Trading Co. (Pvt) Ltd.
Bosgen Inc.,
ChangQing Medical Care Products Co., Ltd.,
Changzhou Munk Foam Technology Co.,Ltd,
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Alba Healthcare,
High Class Dental,
MediSource Inc.,
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Sunrise Medical,
Allen Medical Systems,
Mason Medical Products,
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Alimed, Inc.,
Carrington Labs Inc,
Weaver & Company,
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Innovative Health Care Products, Inc.,
Patterson Medical Products, Inc.,
Contour Technology,
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Sonora Medical Systems,
Cooper Surgical, Inc.,
Z&Z Medical Inc.,
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Alimed, Inc.,
Express Medical Supplies,
Carrington Labs Inc,
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Bio medical device is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. It is also intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.The devices include pacemakers, infusion pumps, the heart-lung machine, dialysis machines, artificial organs, implants, artificial limbs, corrective lenses, cochlear implants, ocular prosthetics, facial prosthetics, somato prosthetics and dental implants.Bio Medical devices can be regulated and classified as class I devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Devices in this category include tongue depressors, bedpans, elastic bandages, examination gloves, and hand-held surgical instruments and other similar types of common equipment. Class II devices are subject to special controls in addition to the general controls of Class I devices. Special controls may include special labeling requirements, mandatory performance standards, and post market surveillance. Devices in this class are typically non-invasive and include x-ray machines, PACS, powered wheelchairs, infusion pumps, and surgical drapes. Class III devices require premarket approval, a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I.
Soma Technology, Inc.,
Venture Medical ReQuip, Inc,
Datascope Corp.,
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Scrub Cabana,
Clinimed, Inc.,
Elmed Inc.,
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Rusch Inc.,
Spiracle Technology,
Cramer Decker Medical,Inc.,
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Crabtree & Evelyn, Ltd.,
High Class Dental,
Halyard Health, Inc.,
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Bio-eye Orbital Implants,
Venture Manufacturing Group Inc.,
Mesa Laboratories, Inc.,
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Medical Equipment is designed to aid in the diagnosis, monitoring or treatment of medical conditions. These devices are usually designed with rigorous safety standards. Diagnostic equipment includes medical imaging machines, used to aid in diagnosis, ultrasound and MRI machines, PET and CT scanners and x-ray machines. Therapeutic equipment includes infusion pumps, medical lasers and LASIK surgical machines. Life support equipment is used maintain a patient's bodily function. These include medical ventilators, heart-lung machines, ECMO and dialysis machines. Medical monitors allow medical staff to measure a patient's medical state. Monitors may measure patient vital signs and other parameters including ECG, EEG, blood pressure and dissolved gases in the blood. Medical laboratory equipment automates or helps analyze blood, urine and genes. Diagnostic Medical Equipment may also be used in the home for certain purposes including the control of diabetes mellitus.
Nation Medical Supplies,
LETMEDCO Inc.,
Barnett,
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Rusch Inc.,
Nation Medical Supplies,
LETMEDCO Inc.,
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Halyard Health, Inc.,
Zimmer, Inc.,
Covidien,
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Unicell, Inc.,
Ethicon, Inc.,
Getinge USA, Inc.,
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Delta Hospital Supply Inc.,
Custom Kits Company, Inc.,
Pemaco, Inc.,
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Qosmedix,
Bay Medical Company Ltd,
Neptune Medical Supply Inc.,
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Delta Hospital Supply Inc.,
Dealmed Medical Supplies,
Home Delivery Medical,
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Medical Arts Press,
MedexSupply,
Brewer Company,
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CPAP Pro,
Sunrise Medical,
The Lab Depot, Inc.,
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Medegen Medical Products, LLC,
Patterson Medical Products, Inc.,
OKT Benelux S.A.
SR Instruments, Inc.,
Pelstar LLC,
Arjo Inc,
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SONO Supplies,
Moore Medical Corporation Inc,
Medical Products Corporation,
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Smith & Nephew
American Environmental Health & Safety,
Dealmed Medical Supplies,
Genlabs,
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Kronring HB,
Heinz Herenz Medizinalbedarf GmbH,
Mank Gmbh, Alfred,
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UVP, Inc.,
HANOVIA Specialty Lighting LLC,
Bulbworks Inc,
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American Environmental Health & Safety,
SONO Supplies,
Acme United Corporation,
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Global Biotechnologies, Inc.
Zimmer, Inc.,
Codman & Shurtleff, Inc.,
Bausch & Lomb,
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High Class Dental,
SKS Science Products,
Vollrath Co., L.L.C., The,
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Delta Hospital Supply Inc.,
Chemlink Laboratories, LLC.,
Brulin & Company, Inc.,
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